This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for A Study to Investigate Sitravatinib as Monotherapy and in Combination With Tislelizumab in Participants With Unresectable Locally Advanced or Metastatic Hepatocellular Carcinoma or Gastric/Gastroesophageal Junction Cancer (NCT03941873), a non-randomized phase 1, phase 2 study. The primary outcome is Number of Participants With Adverse Events.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT03941873 |
| Phase | Phase 1, Phase 2 |
| Condition | Carcinoma, Hepatocellular, Gastric/Gastroesophageal Junction Cancer |
| Allocation | Non-Randomized |
| Design model | Parallel |
| Masking | None (open label) |
| Enrollment | 111 |
| Arms in the primary outcome | n/a |
| Lead sponsor | BeiGene |
| Results posted | Yes |
2. Clinical Question
The study asked whether sitravatinib, given alone or with tislelizumab, could be evaluated for safety, tolerability, pharmacokinetics, and preliminary antitumor activity in participants with unresectable locally advanced or metastatic hepatocellular carcinoma or gastric/gastroesophageal junction cancer. The primary endpoint is safety: the number of participants with treatment-emergent adverse events and serious adverse events.
Population
Participants with unresectable locally advanced or metastatic hepatocellular carcinoma or gastric/gastroesophageal junction cancer. The safety analysis set includes participants who received at least one dose of any study drug.
Intervention
Sitravatinib as monotherapy at 80 mg or 120 mg once daily in 21-day cycles, or sitravatinib at either dose with tislelizumab 200 mg intravenously once every 3 weeks.
Comparator
There was no randomized control group. The study was non-randomized, with four treatment groups; comparisons between these groups are not like-for-like controlled comparisons.
Primary question
How many participants experienced treatment-emergent adverse events or serious adverse events during the reported safety timeframe?
The registry also names duration of response, disease control rate, progression-free survival, and several sitravatinib pharmacokinetic measures as secondary outcomes. However, the posted information contains no results for those measures. It therefore supports a description of the study’s safety counts and design, not an assessment of antitumor activity or a comparison of efficacy between regimens.
Because treatment allocation was not randomized and the groups differ substantially in size, the central question is descriptive. The counts show what was recorded within each group; they do not by themselves show what would have happened to the same participants under another regimen.
3. Trial Design
This was a phase 1/2, non-randomized, parallel study sponsored by BeiGene. The registry lists an enrollment of 111 and a completed status. The recorded start date is 2019-02-28, and the primary completion date is 2023-03-31. The study included participants with unresectable locally advanced or metastatic hepatocellular carcinoma or gastric/gastroesophageal junction cancer.
Four treatment groups are listed: sitravatinib monotherapy at 80 mg, sitravatinib monotherapy at 120 mg, sitravatinib 80 mg with tislelizumab, and sitravatinib 120 mg with tislelizumab. Sitravatinib was taken orally once daily in 21-day cycles. In the combination groups, tislelizumab was given intravenously at 200 mg once every 3 weeks. The registry lists no masking.
The primary safety timeframe is up to approximately 4 years and 1 month. Safety is presented by dose, according to the endpoint description. The safety analysis set is defined as all participants who received at least one dose of any study drug. The group-specific safety counts are displayed in the posted results and should be read as descriptions of each group, not as randomized treatment comparisons.
The registry describes a broad phase 1/2 purpose: safety, tolerability, pharmacokinetics, and preliminary antitumor activity. It does not report the allocation sequence, a randomized assignment procedure, or a masking procedure beyond stating that masking was none. A protocol-level account of dose-escalation decisions, cohort entry, or the way participants were assigned among the four groups is not reported in the registry record.
Although the overall enrollment is recorded, the posted safety groups have their own at-risk counts. These denominators matter when reading each group’s adverse-event counts. The study’s non-randomized structure and uneven group sizes limit direct comparisons, especially because the registry does not establish that participants in different groups had similar characteristics or comparable follow-up.
4. Participant Flow and Accounting
The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.
Overall Study
| Stage | Sitravatinib Monotherapy: 80 mg | Sitravatinib Monotherapy: 120 mg | Sitravatinib 80 mg + Tislelizumab | Sitravatinib 120 mg + Tislelizumab |
|---|---|---|---|---|
| STARTED | 3 | 24 | 3 | 81 |
| COMPLETED | 1 | 3 | 1 | 8 |
| NOT COMPLETED | 2 | 21 | 2 | 73 |
Reasons for not completing this period:
| Reason | Sitravatinib Monotherapy: 80 mg | Sitravatinib Monotherapy: 120 mg | Sitravatinib 80 mg + Tislelizumab | Sitravatinib 120 mg + Tislelizumab |
|---|---|---|---|---|
| Death | 0 | 12 | 2 | 53 |
| Withdrawal by Subject | 1 | 1 | 0 | 5 |
| Lost to Follow-up | 1 | 2 | 0 | 0 |
| Sponsor Decision | 0 | 6 | 0 | 15 |
Analysis population for the primary outcome, as defined in the registry: The Safety Analysis Set includes all participants who received ≥ 1 dose of any study drug
5. Baseline Characteristics
The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.
| Characteristic | Unit | Sitravatinib Monotherapy: 80 mg | Sitravatinib Monotherapy: 120 mg | Sitravatinib 80 mg + Tislelizumab | Sitravatinib 120 mg + Tislelizumab | Total |
|---|---|---|---|---|---|---|
| Participants analysed | 3 | 24 | 3 | 81 | 111 | |
| Age, Continuous | Years | 57.7 (SD 10.02) | 53.3 (SD 9.92) | 56.3 (SD 6.51) | 56.4 (SD 10.23) | 55.7 (SD 10.1) |
| Sex: Female, Male: Female | Participants | 1 | 2 | 1 | 10 | 14 |
| Sex: Female, Male: Male | Participants | 2 | 22 | 2 | 71 | 97 |
| Race/Ethnicity, Customized: Asian: Chinese | Participants | 3 | 24 | 3 | 81 | 111 |
6. Primary Endpoint
The registry lists the primary outcome as Number of Participants With Adverse Events, measured over Up to approximately 4 years and 1 month.
| Element | Registry entry |
|---|---|
| Result type | Count Of Participants |
| Measure of spread | not applicable |
| Unit | Participants |
| Endpoint classification | Binary Endpoint |
The primary endpoint is the number of participants with adverse events. In particular, the registry describes treatment-emergent adverse events and serious adverse events, assessed under National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0. Relevant physical examinations, electrocardiograms, and laboratory assessments are also included in the endpoint description. The stated timeframe is up to approximately 4 years and 1 month.
This is a participant count, rather than a count of every episode or a measure of event severity averaged across participants. A participant may have more than one adverse event, but the endpoint reports whether participants experienced events, with serious and other adverse-event counts presented separately in the posted group results. The registry’s wording does not provide a full event-by-event account in the primary summary.
General statistical context: safety endpoints are used to describe the types and frequency of harms observed during a study. Counts can make clear how many people in a treatment group were recorded as affected, while the denominator indicates how many were at risk in that group. A serious adverse event is a regulatory seriousness category; it is not interchangeable with a rating of symptom intensity. Event seriousness and event severity are distinct concepts in clinical-trial reporting.
The safety endpoint is appropriate to the study’s stated purpose of evaluating safety and tolerability. It cannot, on its own, establish that a drug caused an event or quantify a treatment effect relative to a control. The registry says the safety analysis is presented by dose as prespecified in the statistical analysis plan, but further details of that plan are not reported in the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The posted results give four group-specific safety summaries. In the sitravatinib monotherapy 80 mg group, 1 of 3 participants had a serious adverse event and 3 of 3 had another adverse event. In the sitravatinib monotherapy 120 mg group, 7 of 24 had a serious adverse event and 24 of 24 had another adverse event. In the sitravatinib 80 mg plus tislelizumab group, 2 of 3 had a serious adverse event and 3 of 3 had another adverse event. In the sitravatinib 120 mg plus tislelizumab group, 31 of 81 had a serious adverse event and 78 of 81 had another adverse event.
These are descriptive counts within the groups. They should not be read as evidence that one dose or regimen is safer than another. The allocation was non-randomized, there was no randomized control group, and group sizes vary. The groups may differ in ways that affect both the chance of an adverse event and the time available for events to be observed. The registry does not provide enough information to adjust for those differences or to establish a causal comparison.
The recorded death counts are 0 in the monotherapy 80 mg group, 12 in the monotherapy 120 mg group, 2 in the 80 mg combination group, and 53 in the 120 mg combination group. These counts should be interpreted as the posted group-level death figures, not as evidence that study treatment caused the deaths. The registry summary does not give the cause, timing, relationship to treatment, or individual circumstances for these deaths.
The registry also lists serious adverse-event terms including ileus, intestinal obstruction, death, pneumonia, venous thrombosis limb, and hypersplenism. Several listed terms have 33.3% beside them, while hypersplenism has 4.2%. Those percentages are registry entries, but the summary does not explain the exact denominator or counting conventions for each term. They should not be treated as a group-wide risk estimate or as a basis for ranking treatments.
The table and plots on this page display the posted results without replacing their descriptive character. No inferential analyses are listed in the registry summary: it reports 0 analyses. The results do not include confidence intervals, adjusted estimates, or a randomized treatment contrast. Thus, the most defensible reading is that adverse events were recorded across the four groups, with the reported counts and denominators shown for each. The precision and comparability of those counts are limited, particularly in groups with only 3 participants.
Beyond safety, the study named secondary outcomes for response, disease control, progression-free survival, and sitravatinib pharmacokinetics. Results for these measures are not included in the registry record, so no conclusion about those outcomes can be drawn from this safety summary.
9. Statistical Methods Explained
The posted primary endpoint is a binary participant-level outcome: whether a participant was recorded as having an adverse event in a specified category. The results display the number of participants affected and the number at risk in each treatment group. General statistical context: for a binary outcome, a count is interpreted together with its denominator. A count without its denominator does not convey how common the outcome was within the group, and a denominator alone does not describe the number affected.
What do the group counts represent?
The primary endpoint description distinguishes treatment-emergent adverse events from serious adverse events. The registry says events are assessed according to National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 and includes relevant physical examinations, electrocardiograms, and laboratory assessments. Its posted group summary separates serious adverse-event counts from other adverse-event counts. The count is of participants, not the total number of event episodes; one participant can experience multiple events.
General statistical context: an event count and a participant count answer different questions. Event counts can describe the burden of repeated episodes, while participant counts describe how many people experienced at least one event in a category. A participant-level summary avoids treating multiple events in one person as if they came from different people, but it does not show recurrence or event duration. The registry’s primary summary uses participant counts.
Why does non-randomized allocation matter?
This study is listed as non-randomized and unmasked. In a randomized study, allocation by chance can help balance known and unknown participant characteristics across groups, though it does not guarantee perfect balance. In a non-randomized study, treatment groups can differ at baseline or in other ways. Differences in observed event counts can therefore reflect group composition, exposure, follow-up, or other factors as well as any treatment-related differences. The posted safety counts do not isolate those explanations.
General statistical context: a parallel design means the study has distinct groups receiving different regimens rather than a crossover in which each participant receives multiple regimens. A parallel arrangement does not itself make groups comparable. Here, the registry reports no randomized control group, so the group results are not equivalent to an estimate from a controlled head-to-head trial.
What is the role of the safety analysis set?
The registry defines the safety analysis set as participants who received at least one dose of any study drug. This definition is relevant because safety assessment is tied to exposure: a participant who never received study medication would not be included in that stated set. The endpoint description says that the safety analysis is presented by dose, as prespecified in the statistical analysis plan. Details beyond that statement, including handling of participants who changed dose or how exposure time was summarized, are not reported in the registry record.
General statistical context: defining the analysis population before examining results helps clarify who contributes to an endpoint. Different analysis populations can answer different questions. A safety set based on treatment receipt describes events among exposed participants; it is not automatically the same as a full randomized intention-to-treat population. Since this trial is non-randomized, the latter framework should not be presumed.
How should uncertainty be understood?
General statistical context: a confidence interval is a range of values compatible with the observed data under a specified statistical model. It communicates uncertainty around an estimate, rather than guaranteeing that the true value lies in the interval. Small groups generally yield less precise estimates, because each participant represents a substantial share of the group. The registry entries for this page give counts but do not provide confidence intervals for these safety outcomes.
Similarly, a p-value would address compatibility of data with a particular statistical null hypothesis under a model; it would not establish causation or clinical importance. The registry summary lists 0 analyses and reports no inferential test for the group differences. No statistical significance claim should be made from the displayed counts alone.
What does the sample-size illustration mean?
The page includes a calculated sample-size section based on a planning illustration from the observed effect, with a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. Such calculations describe hypothetical planning requirements under stated assumptions. They are not observed trial outcomes, do not show how this study was designed, and are not observed power. The sample-size justification for the trial is not reported in the registry record. No sample-size values are stated beyond what appears in the separately generated section.
General statistical context: planning estimates depend on assumptions about the effect worth detecting, outcome variability or event frequency, the chosen error rate, and allocation. If those assumptions do not match a future study, the planning estimate may not be informative for that study. The illustration should not be used to infer the actual design rationale or the probability that the present trial detected an effect.
The registry says the safety analysis was prespecified in a statistical analysis plan, but the detailed methods are not reported in the registry record. In particular, this summary does not provide a full missing-data method, adjustment strategy, interim-analysis plan, multiplicity procedure, or model specification. Those methods cannot be reconstructed from the posted counts.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists 13 outcome measures and names several secondary outcomes, including duration of response, disease control rate, progression-free survival, and sitravatinib pharmacokinetic measures. The primary safety outcome itself includes treatment-emergent and serious adverse events. When a study examines multiple outcomes, the chance of observing a seemingly notable result somewhere among them can increase. General statistical context: multiplicity procedures can control that risk, but their use and details must be reported to interpret a collection of hypothesis tests.
The registry summary lists 0 analyses. It does not report a multiplicity adjustment or explain whether secondary outcomes were intended to be descriptive, hypothesis-generating, or confirmatory. A detailed multiplicity strategy is not reported in the registry record. Since no inferential outcome analyses are presented in the registry record used here, there are no reported p-values to interpret as adjusted or unadjusted.
The safety analysis set includes participants who received at least one dose of any study drug. The available summary does not explain how missing safety assessments were handled, whether follow-up differed between groups, or whether participants with incomplete observation were censored or otherwise treated in any time-based analysis. Those details are not reported in the registry record. This matters because observed counts depend on who was assessed and for how long.
The registry gives an overall enrollment of 111 and group-specific at-risk counts in the safety results. It does not provide a complete accounting of participant disposition, missing assessments, or exposure time by group. It is therefore not possible to determine from these registry entries whether all participants had the same opportunity for an event to be observed. The posted counts should be read as the registry reports them, without assuming equal follow-up or complete ascertainment beyond the endpoint description.
11. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| Sitravatinib Monotherapy: 80 mg | 1 | 3 | 33.3% |
| Sitravatinib Monotherapy: 120 mg | 7 | 24 | 29.2% |
| Sitravatinib 80 mg + Tislelizumab | 2 | 3 | 66.7% |
| Sitravatinib 120 mg + Tislelizumab | 31 | 81 | 38.3% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Sitravatinib Monotherapy: 80 mg | 0 of 3 |
| Sitravatinib Monotherapy: 120 mg | 12 of 24 |
| Sitravatinib 80 mg + Tislelizumab | 2 of 3 |
| Sitravatinib 120 mg + Tislelizumab | 53 of 81 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 3% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Sitravatinib Monotherapy: 80 mg | 3 of 3 |
| Sitravatinib Monotherapy: 120 mg | 24 of 24 |
| Sitravatinib 80 mg + Tislelizumab | 3 of 3 |
| Sitravatinib 120 mg + Tislelizumab | 78 of 81 |
Most frequent serious adverse event terms
| Event term | Organ system | Sitravatinib Monotherapy: 80 mg | Sitravatinib Monotherapy: 120 mg | Sitravatinib 80 mg + Tislelizumab | Sitravatinib 120 mg + Tislelizumab |
|---|---|---|---|---|---|
| Death | General disorders | 0 of 3 | 0 of 24 | 1 of 3 | 7 of 81 |
| Pneumonia | Infections and infestations | 1 of 3 | 0 of 24 | 0 of 3 | 3 of 81 |
| Acute coronary syndrome | Cardiac disorders | 0 of 3 | 1 of 24 | 0 of 3 | 1 of 81 |
| Hepatic encephalopathy | Nervous system disorders | 0 of 3 | 0 of 24 | 0 of 3 | 2 of 81 |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | 0 of 3 | 0 of 24 | 0 of 3 | 2 of 81 |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | 0 of 3 | 0 of 24 | 0 of 3 | 2 of 81 |
| Hypersplenism | Blood and lymphatic system disorders | 0 of 3 | 1 of 24 | 0 of 3 | 0 of 81 |
| Myocardial infarction | Cardiac disorders | 0 of 3 | 0 of 24 | 0 of 3 | 1 of 81 |
| Sinus bradycardia | Cardiac disorders | 0 of 3 | 0 of 24 | 0 of 3 | 1 of 81 |
| Abdominal pain | Gastrointestinal disorders | 0 of 3 | 1 of 24 | 0 of 3 | 0 of 81 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Sitravatinib Monotherapy: 80 mg | Sitravatinib Monotherapy: 120 mg | Sitravatinib 80 mg + Tislelizumab | Sitravatinib 120 mg + Tislelizumab |
|---|---|---|---|---|---|
| Proteinuria | Renal and urinary disorders | 2 of 3 | 13 of 24 | 2 of 3 | 44 of 81 |
| Alanine aminotransferase increased | Investigations | 2 of 3 | 13 of 24 | 3 of 3 | 41 of 81 |
| Aspartate aminotransferase increased | Investigations | 2 of 3 | 13 of 24 | 3 of 3 | 41 of 81 |
| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | 2 of 3 | 17 of 24 | 0 of 3 | 31 of 81 |
| Diarrhoea | Gastrointestinal disorders | 2 of 3 | 14 of 24 | 0 of 3 | 27 of 81 |
| Hypoalbuminaemia | Metabolism and nutrition disorders | 1 of 3 | 3 of 24 | 2 of 3 | 34 of 81 |
| Hypertension | Vascular disorders | 3 of 3 | 4 of 24 | 2 of 3 | 28 of 81 |
| Platelet count decreased | Investigations | 2 of 3 | 10 of 24 | 0 of 3 | 22 of 81 |
| Anaemia | Blood and lymphatic system disorders | 1 of 3 | 5 of 24 | 1 of 3 | 22 of 81 |
| Blood creatine phosphokinase MB increased | Investigations | 0 of 3 | 2 of 24 | 1 of 3 | 25 of 81 |
Serious events with the highest arm-level rate: ileus (33.3%), intestinal obstruction (33.3%), death (33.3%), pneumonia (33.3%), venous thrombosis limb (33.3%).
The serious adverse-event figures are participant counts paired with group-specific at-risk totals. The posted results report 1 of 3 in sitravatinib monotherapy 80 mg, 7 of 24 in sitravatinib monotherapy 120 mg, 2 of 3 in sitravatinib 80 mg plus tislelizumab, and 31 of 81 in sitravatinib 120 mg plus tislelizumab. The accompanying other adverse-event counts are 3 of 3, 24 of 24, 3 of 3, and 78 of 81, respectively.
These counts do not indicate how many separate events each participant experienced. They also do not by themselves identify which events were related to treatment. General context: seriousness is a classification distinct from intensity, so a serious event is not necessarily the most severe event by symptom grade. The registry summary reports death counts separately: 0, 12, 2, and 53 across the groups in the order above. It does not establish that those deaths were caused by study treatment.
The smallest groups contain 3 participants, so their counts are especially limited as summaries of a broader population. Group comparisons are further constrained by non-randomized allocation, differing group sizes, and unreported details of follow-up. Read the table as a record of observed safety counts in the study groups, not as a controlled estimate of relative risk.
12. What the Result Does, and Does Not, Mean
The posted data describe safety observations in four groups receiving sitravatinib alone or with tislelizumab. They show how many participants in each group were recorded as having serious adverse events and other adverse events, alongside the at-risk counts. The registry also reports group-level death counts and lists several serious adverse-event terms. These are descriptive findings from the study record.
The counts do not establish that a particular regimen caused an adverse event or death. They also do not show whether one regimen is safer than another. The study was non-randomized, had no randomized control group, and had group sizes ranging from 3 to 81 in the posted safety results. Participants in different groups may not be comparable, and the registry summary does not provide an adjusted comparison that could address such differences.
The study’s stated scope also included pharmacokinetics and preliminary antitumor activity. However, the registry entries do not include results for response, disease control, progression-free survival, or the listed pharmacokinetic measures. The safety counts cannot stand in for those outcomes. Nor do they establish benefit or lack of benefit.
General statistical context: evidence from a clinical study is bounded by its design, the observed participants, how outcomes were measured, and the completeness of follow-up. A result can accurately describe what was recorded without answering a causal question. Here, the group counts are useful for understanding the posted safety record, but not for estimating what would happen under an alternative treatment in otherwise comparable participants.
The registry reports no analyses and no confidence intervals for the safety comparisons in the registry record. The precision of any inferred group-level rate or difference is therefore not quantified. The results should be read as a descriptive account with limited comparative interpretation, rather than as proof of a treatment effect.
13. Why This Trial Matters Statistically
This trial is statistically interesting because it presents safety information across both monotherapy and combination regimens in a phase 1/2 setting. The registry identifies two cancer populations and four dose/regimen groups, while the primary endpoint focuses on participant counts for treatment-emergent and serious adverse events. This makes the distinction between descriptive safety reporting and comparative inference especially important.
The posted group sizes are uneven, and two groups contain only 3 participants. In small groups, each participant has a large influence on the observed count. A count can therefore change markedly with the experience of a single participant, and it offers limited precision about what might be expected in a wider population. General statistical context: estimates from larger groups are often more stable, all else equal, but size alone does not resolve bias or confounding.
The non-randomized structure is another central statistical feature. Without randomized allocation, differences between groups cannot be attributed to treatment regimen alone using these counts. The figures remain useful as a record of events observed in the study, but they are not a like-for-like comparison. The availability of group-specific denominators helps readers interpret the counts, while the absence of inferential estimates and detailed analysis methods limits what can be concluded about uncertainty.
The record also makes clear that safety is only one part of the study’s stated purpose. Response, disease control, progression-free survival, and pharmacokinetic outcomes are named, but their results are not present in this summary. Separating the existence of a measured outcome from the availability of its results prevents the safety table from being overread as a complete evaluation of the study.
Overall, the statistical value of this record lies in seeing how a non-randomized early-phase study reports group-specific safety counts, and in recognizing the limits those design features place on treatment comparisons.
14. Limitations
- The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
- Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.
Several limitations are specific to interpreting this trial’s posted results. First, allocation is non-randomized and the registry explicitly cautions that the arms are not a like-for-like control comparison. Differences in participant characteristics, disease group, or other factors could contribute to differences in observed safety counts; the registry entries do not report enough detail to assess or adjust for those possibilities.
Second, the safety groups are uneven in size. The two groups with 3 participants provide very limited descriptive information, and their counts should not be generalized as precise estimates. Even the larger groups do not remove the lack of a randomized comparison. No confidence intervals or adjusted safety comparisons are included in the available results.
Third, the registry summary does not provide event-level detail, the relationship of events to treatment, timing, duration, recurrence, or participant-specific follow-up. The serious adverse-event term percentages are listed, but their exact denominator and counting conventions are not explained in the summary. Death counts are posted without causes or individual circumstances.
Fourth, the registry reports 0 analyses. Although it names secondary outcomes, results for response, disease control, progression-free survival, and pharmacokinetics are not included in the registry record. Detailed statistical methods, missing-data handling, multiplicity procedures, interim analyses, and the trial’s sample-size justification are not reported in the registry record. These omissions prevent fuller evaluation of analysis choices and outcome completeness.
Finally, the primary endpoint covers a timeframe of up to approximately 4 years and 1 month, but the summary does not give comparable exposure or follow-up time for each group. The counts therefore cannot be interpreted as rates over a common person-time denominator based on the information.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: A Study to Investigate Sitravatinib as Monotherapy and in Combination With Tislelizumab in Participants With Unresectable Locally Advanced or Metastatic Hepatocellular Carcinoma or Gastric/Gastroesophageal Junction Cancer — NCT03941873.
- Registry record last updated 2024-10-26; status last verified 2024-10.
- Results first posted 2024-10-18.
- Data retrieved from ClinicalTrials.gov on 2026-11-09.
- Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.
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18. Record Summary
This completed phase 1/2 study evaluated sitravatinib as monotherapy and with tislelizumab in participants with unresectable locally advanced or metastatic hepatocellular carcinoma or gastric/gastroesophageal junction cancer. It was sponsored by BeiGene, had non-randomized allocation, no masking, a parallel model, and an enrollment of 111. The registry records a start date of 2019-02-28 and a primary completion date of 2023-03-31.
Four groups received sitravatinib at 80 mg or 120 mg, either alone or with tislelizumab. The primary endpoint was the number of participants with treatment-emergent and serious adverse events. The registry’s safety analysis set includes participants who received at least one dose of any study drug. Safety counts are posted by group, alongside death counts and selected serious adverse-event terms.
The study also lists response, disease control, progression-free survival, and pharmacokinetic outcomes, but their results are not included. The available record supports descriptive reading of the posted safety counts; it does not establish comparative treatment effects.