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 of Nofazinlimab (CS1003) in Subjects With Advanced Hepatocellular Carcinoma (NCT04194775), a randomized phase 3 study. The primary outcome is Overall Survival (OS).
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT04194775 |
| Phase | Phase 3 |
| Condition | Hepatocellular Carcinoma |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Quadruple |
| Enrollment | 534 |
| Arms in the primary outcome | 2 |
| Lead sponsor | CStone Pharmaceuticals |
| Results posted | Yes |
2. Clinical Question
Population
Participants had unresectable advanced hepatocellular carcinoma, had received no prior systemic treatment, and could not be eligible for locoregional therapy. The primary analysis population consisted of all randomized participants.
Intervention
Nofazinlimab (CS1003) in combination with lenvatinib.
Comparator
Placebo in combination with lenvatinib. Lenvatinib was the basic treatment in both groups.
Primary question
How did overall survival, defined as time from randomization to death from any cause, compare between the two randomized groups? The registry record reports a median overall survival estimate for each group, but does not report a hazard ratio or other sponsor-reported comparative analysis.
The central statistical question is whether the distribution of time to death differed between the randomized groups, and how precisely the posted estimates characterize that outcome. Overall survival is a time-to-event endpoint: participants are followed until death or, when death has not been observed by the relevant analysis, their follow-up is censored according to the analysis rules. Those rules and the details of censoring are not reported in the registry record.
The comparison is between treatment strategies that both include lenvatinib. It therefore concerns the addition of nofazinlimab to lenvatinib, relative to placebo with lenvatinib, in the population described by the record. It is not a comparison of either combination with no treatment, nor does it isolate the effect of lenvatinib. The record identifies the study as randomized, double-blind, multicenter, phase III, and parallel-group. These design features frame the intended comparison, but do not by themselves provide the missing comparative estimate or establish how uncertainty around the observed group estimates should be interpreted.
3. Trial Design
This is a multicenter, randomized, double-blind, phase III, parallel-group study. The registry record identifies masking as quadruple, but does not specify which people or roles were masked. The study compares nofazinlimab (CS1003) plus lenvatinib with placebo plus lenvatinib as first-line therapy for participants with advanced hepatocellular carcinoma.
The eligible population is described as having unresectable advanced disease, no prior systemic treatment, and no eligibility for locoregional therapy. The record lists hepatocellular carcinoma as the condition. It describes nofazinlimab or its placebo as the investigational product and lenvatinib as the basic treatment. The comparison therefore holds the background treatment constant while varying whether the investigational product is nofazinlimab or placebo.
The registry lists enrollment of 534. The primary outcome analysis population is described as all randomized participants; the posted group estimates include 353 participants in the nofazinlimab plus lenvatinib group and 181 in the placebo plus lenvatinib group. The record does not report the reason for the difference in these group counts or further details of the allocation procedure.
The listed study start date is 2019-12-13, and the listed primary completion date is 2025-06-18. The current registry status is active, not recruiting. The primary outcome timeframe is described as from enrollment to the end of follow-up, with a median of 42.5 months. No detailed schedule of assessments, follow-up procedures, or interim analyses is reported in the registry record. CStone Pharmaceuticals is listed as the sponsor.
Randomization is intended to support a fair comparison of the assigned strategies by reducing systematic differences between groups at allocation. Blinding can reduce the potential for expectations to influence care, assessment, or reporting, although the precise masking arrangements are not described. These design features support interpretation of the comparison, but they do not replace a reported treatment-effect estimate with its uncertainty.
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 | Nofazinlimab + Lenvatinib | Placebo + Lenvatinib |
|---|---|---|
| STARTED | 353 | 181 |
| COMPLETED | 0 | 0 |
| NOT COMPLETED | 353 | 181 |
Reasons for not completing this period:
| Reason | Nofazinlimab + Lenvatinib | Placebo + Lenvatinib |
|---|---|---|
| Death | 253 | 137 |
| Lost to Follow-up | 4 | 2 |
| Withdrawal by Subject | 17 | 7 |
| Treatment ongoing | 28 | 7 |
| Alive in follow-up | 51 | 28 |
Analysis population for the primary outcome, as defined in the registry: Analysis population consisted of all randomized participants
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 | Nofazinlimab + Lenvatinib | Placebo + Lenvatinib | Total |
|---|---|---|---|---|
| Participants analysed | 353 | 181 | 534 | |
| Age, Categorical: <=18 years | Participants | 0 | 0 | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 244 | 147 | 391 |
| Age, Categorical: >=65 years | Participants | 109 | 34 | 143 |
| Age, Continuous | years | 57.1 (SD 11.23) | 53.7 (SD 11.77) | 56.0 (SD 11.52) |
| Sex: Female, Male: Female | Participants | 50 | 29 | 79 |
| Sex: Female, Male: Male | Participants | 303 | 152 | 455 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 0 | 0 | 0 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 353 | 181 | 534 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Asian | Participants | 338 | 171 | 509 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Black or African American | Participants | 0 | 1 | 1 |
| Race (NIH/OMB): White | Participants | 15 | 9 | 24 |
| Race (NIH/OMB): More than one race | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 |
| Region of Enrollment: China | participants | 322 | 166 | 488 |
| Region of Enrollment: Taiwan | participants | 16 | 4 | 20 |
| Region of Enrollment: Spain | participants | 9 | 7 | 16 |
| Region of Enrollment: Poland | participants | 6 | 4 | 10 |
| Eastern Cooperative Oncology Group Performance Status: ECOG = 0 | Participants | 148 | 77 | 225 |
| Eastern Cooperative Oncology Group Performance Status: ECOG = 1 | Participants | 205 | 104 | 309 |
6. Primary Endpoint
The registry lists the primary outcome as Overall Survival (OS), measured over From enrollment to end of follow-up, a median of 42.5 months.
| Element | Registry entry |
|---|---|
| Result type | Median |
| Measure of spread | 95% Confidence Interval |
| Unit | months |
| Endpoint classification | Time-to-Event Analysis |
The primary endpoint is overall survival. It measures the time interval from randomization to death from any cause. The registry record describes the endpoint as a median time in months and gives the timeframe as from enrollment to the end of follow-up, with a median of 42.5 months. The analysis population is all randomized participants.
Overall survival is used in clinical trials because it is a direct, clinically meaningful time-to-event outcome: the event is death, rather than a change in a laboratory measure or an assessment of tumor response. In general, a median survival estimate is the time by which half of the relevant event-time distribution has occurred, as estimated by the analysis. It describes the middle of the distribution; it does not describe every participant’s outcome or the full shape of survival over time.
For the nofazinlimab plus lenvatinib group, the posted median is 21.6 months, with a 95% confidence interval from 18.6 to 24.6 months. For the placebo plus lenvatinib group, the posted median is 18.5 months, with a 95% confidence interval from 14.7 to 21.8 months. These are separate group estimates. The registry record does not report a hazard ratio, a confidence interval for a between-group contrast, or a sponsor-reported test of the primary comparison. Separate medians and their confidence intervals do not, on their own, quantify the uncertainty of a treatment contrast.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The posted primary outcome estimates are median overall survival of 21.6 months for nofazinlimab plus lenvatinib and 18.5 months for placebo plus lenvatinib. The corresponding 95% confidence intervals are 18.6 to 24.6 months and 14.7 to 21.8 months. These figures describe the estimated median time to death in each group under the registry’s endpoint definition and analysis population.
A confidence interval expresses uncertainty about an estimated quantity under the assumptions of the analysis. It is not a range containing a known proportion of individual participants’ survival times, and it does not state the probability that the true value lies within the particular interval. The intervals around the two medians overlap. However, comparing overlap between separate confidence intervals is not a substitute for an interval or test for the between-group effect. The registry record does not report a hazard ratio, a confidence interval for a comparative effect, or a p-value for overall survival. The group medians therefore should not be treated as a complete statistical test of the primary question.
The outcome timeframe is described as extending from enrollment to the end of follow-up, with a median follow-up of 42.5 months. Follow-up duration matters for time-to-event outcomes because participants may have different lengths of observation, and some may not have experienced the event by the analysis. The record does not describe censoring rules, the number of deaths used in the primary analysis, or the method used to estimate the medians. Those details are not reported in the registry record, so the posted summaries do not allow a fuller assessment of the survival analysis.
The record also posts secondary outcomes, including response and disease-control measures assessed by independent central review or investigators. The broad pattern is that response outcomes are numerically higher in the nofazinlimab group, while the centrally assessed disease-control estimates are close between groups. These secondary findings are not substitutes for the primary overall-survival comparison. Their estimates and unadjusted comparisons should be interpreted in light of the number of outcomes assessed and the absence of reported multiplicity procedures.
In short, the registry record supplies group-level primary endpoint estimates with confidence intervals, but not a sponsor-reported comparative survival analysis. The estimates describe what was observed in the posted groups; they do not, by themselves, establish the magnitude or precision of a treatment effect. A fuller interpretation would require the comparative estimate and its uncertainty, along with the analysis details that are not reported in the registry record.
9. Statistical Methods Explained
The primary endpoint is a time-to-event measure, while several secondary outcomes are percentages of participants meeting response or disease-control criteria. These outcome types require different statistical summaries. The registry record posts group estimates for the primary endpoint and secondary outcomes, but it does not report sponsor analyses for the comparisons listed with the secondary results.
What does a median survival estimate describe?
In general, the median of a time-to-event distribution is the estimated time at which the cumulative share of participants experiencing the event reaches one half. For overall survival, the event is death from any cause. A median gives a single summary of the survival distribution, but does not describe the whole curve or tell how the groups compare at every time point. It can also be difficult to estimate precisely when follow-up or the number of observed events is limited. The registry record does not report the estimation method or event count for the primary analysis.
How should the confidence intervals be read?
The posted 95% confidence intervals quantify uncertainty around each group’s median under the analysis assumptions. In general, a confidence interval is generated by a procedure that, over repeated studies under its assumptions, would cover the target quantity at the stated rate. It is not a statement that a particular individual’s outcome falls in the interval, nor is it a direct probability statement about the fixed value for this study. A confidence interval for each arm is also not the same thing as a confidence interval for the difference or ratio between arms. The record does not provide a comparative interval for overall survival.
Why is a comparative survival analysis important?
In general, survival comparisons often use methods that account for the timing of events and censoring, rather than comparing only the two medians. A hazard ratio is one possible summary of a relative event rate over follow-up, but its interpretation depends on the model and assumptions used. The registry record does not report a primary hazard ratio, its confidence interval, or a p-value. It also does not report the specific survival-analysis method or proportional-hazards assessment. No such analysis can be inferred from the posted medians alone.
How are the binary outcomes summarized?
For the secondary response and disease-control outcomes, the record posts the percentage of participants meeting the outcome in each group, along with 95% confidence intervals. The comparison summaries include unadjusted recalculations from the posted counts and group sizes. In general, a risk difference expresses the difference between two proportions, while a risk ratio compares them as a ratio. An odds ratio compares the odds of the outcome. These are different effect measures and need not have the same numerical value or interpretation. The unadjusted p-values describe comparisons without a reported adjustment for multiple testing. No sponsor-reported analyses are listed for these secondary outcomes.
The secondary confidence intervals describe uncertainty in the group percentages, while the comparison intervals describe uncertainty in the recalculated contrasts. Because these are simple unadjusted recalculations, they should not be mistaken for the sponsor’s prespecified analysis. The registry record does not report a formal analysis plan for these comparisons or explain whether they were prespecified. For the primary endpoint, the record notes that values were missing or not estimable for a two-arm comparison of the median-time endpoint; consequently, no recalculated comparative estimate is posted for that outcome.
What do the planning illustrations mean?
The planning illustrations are not observed power and are not the trial’s original design justification. They use the observed effect as a reference and show planning quantities for specified fractions of that effect. The stated assumptions are a two-sided significance level of 0.05, equal allocation between the two arms, and a normal approximation. The illustrations give participants per arm for 80% power and participants per arm for 90% power for the binary outcomes. In general, such quantities depend strongly on the assumed effect: planning to detect a smaller effect requires more participants under otherwise fixed assumptions. These figures are conditional illustrations, not evidence that the trial was designed with those assumptions or that it achieved a particular power. The trial’s own sample-size justification is not reported in the registry record.
General statistical concepts can clarify what the posted summaries do and do not show, but they cannot fill in unreported analysis choices. The registry record does not report the handling of missing outcome data, the censoring rules, the multiplicity strategy, or whether any interim analyses were planned or conducted. Those omissions limit assessment of the precision and confirmatory status of the posted comparisons.
10. Multiplicity, Missing Data and Analysis Populations
The registry record lists overall survival as the primary outcome and identifies 13 outcome measures, with 12 secondary outcomes posted. It does not report a statistical testing hierarchy, a multiplicity adjustment, or which secondary outcomes were intended to support confirmatory claims. The binary-outcome comparisons include unadjusted p-values. These values should be read as unadjusted comparisons rather than as results protected against the accumulation of tests across multiple outcomes.
In general, multiplicity matters because testing many outcomes can increase the chance of obtaining one or more small p-values by chance, even when no underlying effects exist. Trial protocols can address this by specifying a limited hierarchy, adjusting significance thresholds, or treating secondary outcomes as exploratory. Which, if any, approach was used is not reported in the registry record. The absence of a reported procedure does not establish that none was used; it means the registry entry does not allow the reader to assess it.
The primary analysis population is stated to include all randomized participants. The record does not give detailed analysis populations for each secondary endpoint, explain whether all randomized participants were included in every analysis, or describe exclusions. Missing-data methods are not reported in the registry record. For the time-to-event outcome, the record also does not specify censoring rules, the number of deaths analyzed, or how incomplete follow-up was handled. For binary outcomes, it does not describe how participants with unevaluable assessments or missing response data were treated.
The registry record reports a median follow-up duration of 42.5 months, but does not report interim analyses or their timing. It also does not provide a detailed statistical analysis plan, sample-size justification, or rules for final analysis. These gaps limit assessment of whether analyses were prespecified, how missing observations affected the estimates, and how the final results relate to any planned decision framework. The posted group estimates remain interpretable as registry summaries, but their inferential context is incomplete.
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 |
|---|---|---|---|
| Nofazinlimab + Lenvatinib | 138 | 352 | 39.2% |
| Placebo + Lenvatinib | 55 | 181 | 30.4% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Nofazinlimab + Lenvatinib | 253 of 352 |
| Placebo + Lenvatinib | 137 of 181 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 5% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Nofazinlimab + Lenvatinib | 343 of 352 |
| Placebo + Lenvatinib | 180 of 181 |
Most frequent serious adverse event terms
| Event term | Organ system | Nofazinlimab + Lenvatinib | Placebo + Lenvatinib |
|---|---|---|---|
| Death | General disorders | 10 of 352 | 3 of 181 |
| Aspartate aminotransferase increased | Investigations | 12 of 352 | 1 of 181 |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | 6 of 352 | 6 of 181 |
| Hepatic function abnormal | Hepatobiliary disorders | 7 of 352 | 5 of 181 |
| Pneumonia | Infections and infestations | 8 of 352 | 4 of 181 |
| Hepatic encephalopathy | Nervous system disorders | 10 of 352 | 0 of 181 |
| Ascites | Gastrointestinal disorders | 4 of 352 | 4 of 181 |
| Alanine aminotransferase increased | Investigations | 7 of 352 | 1 of 181 |
| Asthenia | General disorders | 4 of 352 | 3 of 181 |
| Blood bilirubin increased | Investigations | 7 of 352 | 0 of 181 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Nofazinlimab + Lenvatinib | Placebo + Lenvatinib |
|---|---|---|---|
| Proteinuria | Renal and urinary disorders | 203 of 352 | 103 of 181 |
| Platelet count decreased | Investigations | 172 of 352 | 89 of 181 |
| Hypothyroidism | Endocrine disorders | 152 of 352 | 71 of 181 |
| Hypertension | Vascular disorders | 142 of 352 | 72 of 181 |
| Weight decreased | Investigations | 133 of 352 | 51 of 181 |
| Aspartate aminotransferase increased | Investigations | 116 of 352 | 66 of 181 |
| Diarrhoea | Gastrointestinal disorders | 118 of 352 | 59 of 181 |
| Blood bilirubin increased | Investigations | 109 of 352 | 62 of 181 |
| Alanine aminotransferase increased | Investigations | 106 of 352 | 55 of 181 |
| White blood cell count decreased | Investigations | 103 of 352 | 52 of 181 |
Serious events with the highest arm-level rate: aspartate aminotransferase increased (3.4%), upper gastrointestinal haemorrhage (3.3%), death (2.8%), hepatic encephalopathy (2.8%), hepatic function abnormal (2.8%).
The safety summaries report serious adverse events and other adverse events for the two groups, with the number at risk stated for each category. In the nofazinlimab plus lenvatinib group, serious adverse events affected 138 of 352 participants at risk, and other adverse events affected 343 of 352. In the placebo plus lenvatinib group, serious adverse events affected 55 of 181 participants at risk, and other adverse events affected 180 of 181. The registry also reports deaths of 253 and 137 in the respective groups.
These are group-level counts, not a comparison adjusted for follow-up time or participant characteristics. The record does not provide a formal comparative safety analysis, event rates over time, or attribution of each event to a specific treatment. The deaths listed in the safety summary should not be assumed to be treatment-related; overall survival separately defines death from any cause as its endpoint.
The listed serious adverse-event terms include aspartate aminotransferase increased at 3.4%, upper gastrointestinal haemorrhage at 3.3%, death at 2.8%, hepatic encephalopathy at 2.8%, hepatic function abnormal at 2.8%, and pneumonia at 2.3%. These figures describe the terms and percentages posted in the registry record. They do not, by themselves, establish causation or provide a complete comparison of safety between groups. Further details on event severity, timing, relatedness, and handling of repeated events are not reported in the registry record.
12. What the Result Does, and Does Not, Mean
The results establish that the registry record contains group-level estimates for overall survival and selected secondary outcomes in a randomized comparison of nofazinlimab plus lenvatinib against placebo plus lenvatinib. For the primary endpoint, the posted medians are 21.6 months and 18.5 months, respectively, with a 95% confidence interval for each group. These estimates describe the observed summaries in the listed analysis groups.
They do not provide a complete estimate of the comparative effect on overall survival. The registry record does not report a hazard ratio, a confidence interval for a between-group survival contrast, or a sponsor-reported p-value for the primary endpoint. Separate medians cannot replace those comparative results. Nor do the posted results establish how outcomes would differ in populations outside the described eligibility criteria or in treatment settings that do not use lenvatinib in both groups.
The secondary response and disease-control outcomes offer additional descriptions of tumor-related outcomes, but their unadjusted comparisons have less confirmatory weight in the absence of a reported multiplicity plan. They should not be treated as proof of a survival effect. Safety counts likewise summarize reported events but do not establish treatment causation or provide a fully adjusted comparison.
In general, randomized assignment can support causal interpretation when the design, conduct, follow-up, and analysis are appropriate. The registry entry identifies randomization and blinding, but does not report enough detail to evaluate every aspect of conduct or analysis. Missing-data procedures, censoring rules, the primary comparative model, and interim-analysis plans are not reported in the registry record. The appropriate reading is therefore bounded: the posted data describe group estimates and event counts, while important information needed to assess comparative uncertainty and confirmatory inference is not available in the registry record.
13. Why This Trial Matters Statistically
This trial is statistically notable for pairing a clinically direct time-to-event primary outcome with several secondary measures that capture response and disease control. The design compares two strategies that both include lenvatinib, so the intended randomized contrast concerns adding nofazinlimab rather than starting lenvatinib versus not using it. The registry record identifies the study as phase III, randomized, double-blind, multicenter, and parallel-group.
The primary result highlights an important distinction between describing each arm and estimating a treatment contrast. The posted median survival estimates and their confidence intervals allow readers to understand the group-level summaries, but the record does not include a sponsor-reported hazard ratio or comparative confidence interval. A treatment comparison is most informative when it includes both an effect estimate and its uncertainty. Without those elements, the primary outcome cannot be fully evaluated from the posted summary alone.
The secondary outcomes also demonstrate why endpoint definitions and assessment methods matter. Investigator-assessed and centrally assessed outcomes can differ, and response measures need not follow the same pattern as disease-control measures. Their unadjusted comparisons are useful as descriptive context, but absent a reported multiplicity strategy they should not be assigned the same confirmatory weight as a clearly specified primary analysis.
Finally, the record illustrates the importance of reporting analysis details alongside results. The population for the primary analysis is identified, but censoring, missing data, interim analyses, and the statistical plan are not described. Those details affect how precisely and confidently readers can interpret the estimates. The value of the posted results is therefore in documenting the observed summaries while making clear where comparative and methodological information remains unavailable.
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 the registry information available for this trial. The primary endpoint is summarized by separate group medians and confidence intervals, but a sponsor-reported comparative survival estimate is not reported in the registry record. The comparative hazard ratio, its uncertainty, and a primary p-value are therefore unavailable in the posted results. The values for each group should not be used to construct a new comparison by subtracting the medians or comparing their separate confidence intervals.
The record describes a median follow-up of 42.5 months but does not report the number of deaths used in the primary analysis, the censoring rules, or the survival estimation method. It does not describe missing-data handling for the secondary outcomes or provide detailed endpoint-specific analysis populations. These omissions make it difficult to assess how incomplete observations and differing follow-up could affect the estimates.
There are posted response outcomes assessed by both a blinded independent central review committee and investigators. This provides more than one assessment perspective, but the record does not explain how differences between assessors were handled or designate a hierarchy among the secondary outcomes. The unadjusted recalculations do not address multiplicity, and no confirmatory testing strategy is reported.
The registry record does not report the sample-size justification, the full statistical analysis plan, or whether interim analyses were planned or conducted. It also does not provide the detailed masking roles or enough information to evaluate the conduct of follow-up. The posted group sizes differ, but the reason is not reported in the registry record. These are limits on interpretation of the available registry summaries; they do not, by themselves, show that trial procedures were inadequate.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: A Study of Nofazinlimab (CS1003) in Subjects With Advanced Hepatocellular Carcinoma — NCT04194775.
- Registry record last updated 2026-07-30; status last verified 2026-06.
- Results first posted 2026-07-30.
- 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
The registry record describes NCT04194775, a randomized, double-blind, multicenter, parallel-group phase III study sponsored by CStone Pharmaceuticals. It evaluates nofazinlimab (CS1003) plus lenvatinib against placebo plus lenvatinib as first-line therapy for unresectable advanced hepatocellular carcinoma in participants with no prior systemic treatment who are not eligible for locoregional therapy.
Enrollment is listed as 534, and the primary outcome is overall survival from randomization to death from any cause among all randomized participants. The posted median estimates are 21.6 months for nofazinlimab plus lenvatinib and 18.5 months for placebo plus lenvatinib. The registry record does not report a sponsor-reported comparative survival analysis. Secondary outcomes include response, progression-free survival, duration of response, and disease control. The record lists the study as active, not recruiting, with a primary completion date of 2025-06-18.