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 TAS 102 in Combination With Ramucirumab in Advanced, Refractory Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma (NCT03686488), a na phase 2 study. The primary outcome is Overall Survival.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT03686488 |
| Phase | Phase 2 |
| Condition | Gastric Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma, Gastric Cancer |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 23 |
| Arms in the primary outcome | n/a |
| Lead sponsor | H. Lee Moffitt Cancer Center and Research Institute |
| Results posted | Yes |
2. Clinical Question
The study asks about overall survival after starting concurrent TAS 102 and ramucirumab in people with advanced, refractory gastric or gastroesophageal junction adenocarcinoma. Its stated purpose also includes assessing safety and effectiveness. The primary endpoint is overall survival, defined as time from starting on trial to death from any cause, with the primary outcome timeframe recorded as 6 months.
Population
People with advanced, refractory gastric or gastroesophageal junction adenocarcinoma. The registry record lists gastric adenocarcinoma, gastroesophageal junction adenocarcinoma, and gastric cancer as conditions.
Intervention
TAS 102 and ramucirumab administered concurrently. The registry names TAS 102 and ramucirumab 10 MG/ML intravenous solution.
Comparator
There is no separate comparator group in this single-group study. Allocation is recorded as NA, and the registry does not describe a randomized comparison.
Primary question
What overall survival is observed after starting the combination, as measured from trial entry to death from any cause? The median and its 95% confidence interval are not reported in the registry record.
Because the design has a single treatment group, the study can describe outcomes among participants treated with the combination. It cannot, by itself, establish how those outcomes compare with a concurrent untreated group or with another treatment. The registry record does not report a separate control regimen or a between-group estimate.
3. Trial Design
This is a phase II study with a single-group model. The listed enrollment is 23, and the record identifies TAS 102 and ramucirumab as the study interventions, administered concurrently. Allocation is recorded as NA, and masking is listed as none. The registry status is completed. The study start date is 2018-12-20 and the primary completion date is 2022-01-19.
These design details determine the scope of statistical interpretation. With a single group, reported outcomes characterize the participants enrolled in the study; there is no parallel control arm for a randomized treatment contrast. The posted design therefore does not support attributing a difference in outcome to the combination relative to another treatment. A historical or external comparison is not described in the registry record.
The registry lists overall survival as the primary outcome, with a 6 months timeframe. Secondary outcomes include the number of participants with at least one adverse event, progression free survival, and objective response rate. Four outcome measures are recorded, but no outcome estimates for the primary endpoint are included in the registry record for this analysis. The registry record also does not report a statistical analysis plan, eligibility details beyond the disease population, or a description of how participants were selected for any particular analysis.
The record identifies H. Lee Moffitt Cancer Center and Research Institute as sponsor. The combination is described as concurrent administration of TAS 102 (Lonsurf) and ramucirumab (CYRAMZA). No additional treatment schedule, dose information for TAS 102, or protocol-level treatment modification details are reported in the registry record. Those omissions limit what can be inferred about treatment exposure and implementation.
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 | TAS 102 and Ramucirumab |
|---|---|
| STARTED | 23 |
| COMPLETED | 23 |
| NOT COMPLETED | 0 |
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 | TAS 102 and Ramucirumab |
|---|---|---|
| Participants analysed | 23 | |
| Age, Categorical: <=18 years | Participants | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 13 |
| Age, Categorical: >=65 years | Participants | 10 |
| Sex: Female, Male: Female | Participants | 3 |
| Sex: Female, Male: Male | Participants | 20 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 1 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 22 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 0 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 |
| Race (NIH/OMB): Asian | Participants | 1 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 |
| Race (NIH/OMB): Black or African American | Participants | 0 |
| Race (NIH/OMB): White | Participants | 22 |
| Race (NIH/OMB): More than one race | Participants | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 |
| Region of Enrollment: United States | participants | 23 |
6. Primary Endpoint
The registry lists the primary outcome as Overall Survival, measured over 6 months.
| Element | Registry entry |
|---|---|
| Result type | Median |
| Measure of spread | 95% Confidence Interval |
| Unit | months |
| Endpoint classification | Time-to-Event Analysis |
Overall survival measures the time from starting on trial to death from any cause. It is a time-to-event endpoint: the event is death, and the recorded time is the interval between trial entry and that event. The registry specifies the median as the summary measure and a 95% confidence interval as its dispersion, with a 6 months timeframe.
In general, overall survival is used because it has a clearly defined event and captures survival regardless of the specific cause of death. A median describes the time by which half of the relevant survival distribution has experienced the event, subject to the analysis method and available follow-up. It is not an average, and it does not describe every participant’s experience.
A confidence interval communicates uncertainty around an estimate. Its width helps readers judge how precisely the median has been estimated; it is not a range that contains a fixed proportion of individual survival times. The registry record does not report the median overall survival or its 95% confidence interval, so neither the estimated survival time nor its precision can be assessed from the posted results.
The registry definition does not specify additional analysis details, such as the censoring rules or the population included in the endpoint analysis. Those details are not reported in the registry record. They matter because time-to-event estimates depend on how follow-up and incomplete observation are handled.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The main interpretive constraint is that the registry entries available in the registry record define the primary outcome but do not give its estimate. Overall survival is identified as the primary endpoint, with the median and a 95% confidence interval specified as the intended summary, but the median and interval are not reported in the registry record. Thus the posted information does not establish the observed survival estimate or how precisely it was estimated.
The trial is single-group, not a randomized comparison. Its outcomes can describe the enrolled group receiving TAS 102 with ramucirumab, but there is no concurrent control group against which to estimate a treatment contrast. Even if an outcome estimate were available, interpreting it as an effect caused by treatment would require a comparison design and assumptions not established by this record. Differences in prognosis, participant selection, follow-up, and care can affect comparisons with other groups.
The enrollment listed in the record is 23. That is a registry enrollment figure, not confirmation of the number included in each endpoint analysis. The number analyzed for overall survival, the number of deaths used in its estimate, and the amount of follow-up contributing to the analysis are not reported in the registry record. Although the adverse-event record lists deaths for the treatment group, that count alone does not provide the overall-survival estimate or its analysis population.
The posted serious adverse event information is also descriptive. It lists 7 participants with at least one serious adverse event among 23 at risk. The record lists 23 participants with at least one other adverse event among 23 at risk, and 20 deaths. These figures do not specify whether events were judged related to treatment, the observation period for each participant, or the detailed rules used to classify events. The death count should not be treated as a treatment-related death count.
No sponsor hazard ratio is reported among the analysis information described in the registry record. A hazard ratio would compare event rates over time between groups, so it would not supply a randomized comparison in this single-group design. The registry entries also do not provide estimates for progression free survival or objective response rate. The registry lists them as secondary outcomes, but their values are not reported in the registry record.
Consequently, the available statistical information supports a description of study design and the recorded adverse-event counts, but not a quantitative assessment of the primary survival result. The record does not permit a judgment about the direction, magnitude, or precision of an overall-survival estimate because the estimate itself is absent. It also does not support a claim of comparative benefit or lack of benefit.
9. Statistical Methods Explained
Overall survival is a time-to-event outcome. The registry defines the event as death from any cause and the time origin as starting on trial. It specifies the median and a 95% confidence interval as the summary and uncertainty measure. The actual median and confidence interval are not reported in the registry record. General statistical explanation below describes what these methods mean, rather than claiming that unreported analysis procedures were used.
What does a median survival estimate describe?
In general, a median time-to-event estimate identifies the point in the estimated survival distribution at which the probability of remaining event-free has reached the halfway point. It describes the distribution rather than the exact experience of any particular participant. Unlike a mean, a median does not require assigning a complete event time to every participant. The interpretation still depends on the analysis population, the observed follow-up, and how incomplete follow-up is handled. Those implementation details are not reported in the registry record.
The listed 6 months timeframe should be read as the registry’s stated outcome timeframe, not as a reported median or as evidence that every participant was followed for that duration. The record does not give participant-level follow-up, a follow-up summary, or a data cutoff for the survival estimate. It is therefore not possible to reconstruct the time-to-event analysis from the registry information.
What does a confidence interval contribute?
In general, a confidence interval expresses the statistical uncertainty around an estimate under the assumptions of the analysis. A narrower interval indicates greater precision, while a wider interval indicates less precision. The interval does not show the range of individual outcomes, and it is not a guarantee that the true value lies within its endpoints. Interpretation requires both the estimate and its interval, along with the analysis assumptions.
The registry specifies a 95% confidence interval for the median overall survival but does not report either endpoint of that interval. As a result, the stated confidence level alone cannot show the precision of the survival estimate. It also cannot indicate whether the estimate is compatible with a particular comparison value; no such comparison value or estimate is provided in the registry entries.
Why do time-to-event analyses address incomplete follow-up?
In general, some participants may not have experienced the event by the end of observation, or their later event status may be unavailable. Time-to-event methods can use the information observed up to the last known time without treating such a participant as though the event occurred at that time. This is commonly handled through censoring. The validity of the resulting estimate depends on appropriate definitions of follow-up and assumptions about why observation ended.
The registry record does not report censoring rules, reasons for incomplete observation, or the number of participants censored. No specific censoring method or assumption should therefore be attributed to this study from the available record. These omissions are relevant to understanding how the reported median would have been estimated, if an estimate were posted.
What can a single-group design estimate?
In general, a single-group study can estimate outcomes observed in its enrolled group. It does not directly estimate the difference between the intervention and a control treatment because a control group is absent. An estimate within the treatment group may be affected by participant characteristics, disease course, other care, and follow-up. A comparison with another study or historical group would require comparable populations and methods, and those comparisons are not described in the registry record.
Allocation is recorded as NA, masking as none, and the model as single group. These are design descriptors, not outcome findings. The record does not describe random assignment, a masked outcome assessment process, or a comparative statistical model. No causal effect estimate can be inferred from the single-group designation alone.
How should hazard ratios be understood?
In general, a hazard ratio compares the instantaneous event rates between groups over the observed follow-up, subject to the model and its assumptions. It is not the same as a ratio of median survival times and is not a direct statement about how long a particular person will live. Its interpretation requires a comparison group and details about the model. No sponsor hazard ratio is reported in the analysis information described in the registry record; no comparative hazard-ratio interpretation can be made for this single-group study.
What do the planning assumptions mean?
The planning illustration associated with the posted material is described as using a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. It defines the target effect as a stated fraction of the observed effect. For time-to-event planning, the illustration concerns total events using the Schoenfeld approach; other planning results are expressed as participants per arm. These assumptions describe a planning exercise, not the design actually recorded for this single-group trial.
Any such sample-size values are planning illustrations based on the observed effect, not observed power and not a report of the trial’s original design justification. The registry record does not report the trial’s sample-size justification or a two-arm allocation plan. Since no observed primary effect estimate is reported in the registry record, the planning assumptions alone cannot establish whether the study was adequately sized for its primary endpoint.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists overall survival as the primary outcome and also lists secondary outcomes: number of participants with at least one adverse event, progression free survival, and objective response rate. Listing several outcomes raises a general issue of multiplicity: when many hypotheses are tested, the chance of at least one apparently notable result can increase. Researchers may address this through prespecification, adjustment, or a hierarchy of outcomes, but the registry record does not report a multiplicity strategy. No adjustment or testing hierarchy should be assumed.
The record lists four outcome measures, while the analysis information described in the registry contains no analysis records. The outcome values for the primary endpoint and the named secondary efficacy outcomes are not reported in the registry record. There is therefore no basis for assessing how many statistical tests were performed, which analyses were designated primary, or whether any adjustment was applied.
Missing-data handling is also not reported in the registry record. For overall survival, relevant details include how follow-up ends, how incomplete observation is treated, and which participants contribute to the estimate. For other outcomes, the record does not specify the analysis population, handling of unevaluable participants, or rules for missing assessments. These are not details that can be inferred from the enrollment figure.
The registry record does not report interim analyses, a detailed statistical analysis plan, or analysis-population definitions. It also does not specify whether the primary analysis included all enrolled participants or a subset. These gaps limit reproducibility and make it difficult to assess whether analyses followed a prespecified plan. The absence of these details is not evidence that a particular method was or was not used; it means the method is not reported in the registry record.
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 |
|---|---|---|---|
| TAS 102 and Ramucirumab | 7 | 23 | 30.4% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| TAS 102 and Ramucirumab | 20 of 23 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 0% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| TAS 102 and Ramucirumab | 23 of 23 |
Most frequent serious adverse event terms
| Event term | Organ system | TAS 102 and Ramucirumab |
|---|---|---|
| Death NOS | General disorders | 3 of 23 |
| Sudden death NOS | General disorders | 1 of 23 |
| Multi-organ failure | General disorders | 1 of 23 |
| Flu like symptoms | General disorders | 1 of 23 |
| Infections and infestations- Other | Infections and infestations | 1 of 23 |
| Abdominal pain | Gastrointestinal disorders | 1 of 23 |
| Upper gastrointestinal hemorrhage | Gastrointestinal disorders | 1 of 23 |
| Stroke | Vascular disorders | 1 of 23 |
| Colonic hemorrhage | Gastrointestinal disorders | 1 of 23 |
| Cough | Respiratory, thoracic and mediastinal disorders | 1 of 23 |
Most frequent non-serious adverse event terms
| Event term | Organ system | TAS 102 and Ramucirumab |
|---|---|---|
| Fatigue | General disorders | 14 of 23 |
| Diarrhea | Gastrointestinal disorders | 13 of 23 |
| Nausea | Gastrointestinal disorders | 13 of 23 |
| Vomiting | Gastrointestinal disorders | 12 of 23 |
| Headache | Nervous system disorders | 11 of 23 |
| Hypertension | Vascular disorders | 9 of 23 |
| Constipation | Gastrointestinal disorders | 6 of 23 |
| Dizziness | Nervous system disorders | 6 of 23 |
| Neutrophil count decreased | Investigations | 6 of 23 |
| Anorexia | Metabolism and nutrition disorders | 6 of 23 |
Serious events with the highest arm-level rate: death nos (13.0%), sudden death nos (4.3%), multi-organ failure (4.3%), flu like symptoms (4.3%), infections and infestations- other (4.3%).
The adverse-event record lists 7 participants with at least one serious adverse event among 23 at risk in the TAS 102 and ramucirumab group. It also lists 23 participants with at least one other adverse event among 23 at risk, and records 20 deaths. These are descriptive counts from the registry record, not estimates of comparative risk against a control group.
The listed serious adverse-event terms include Death NOS at 13.0%, Sudden death NOS at 4.3%, Multi-organ failure at 4.3%, Flu like symptoms at 4.3%, Infections and infestations- Other at 4.3%, and Abdominal pain at 4.3%. The record does not clarify in the registry record whether participants could contribute to more than one term, or how each term maps to the participant-level count. The percentages should therefore be read as reported event-term figures, not added together or interpreted as mutually exclusive categories.
General caution is needed when interpreting adverse-event summaries. Counts do not by themselves establish that an event was caused by treatment, and the record does not report the treatment attribution, event timing, duration, severity grading, or exposure time. The 20 deaths are not identified in the registry entries as treatment-related. The registry record also does not provide a comparator group that would permit a like-for-like safety contrast.
12. What the Result Does, and Does Not, Mean
The registry record establishes that this was a completed phase II, single-group study of concurrent TAS 102 and ramucirumab in advanced, refractory gastric or gastroesophageal junction adenocarcinoma. It identifies overall survival as the primary endpoint and defines it as time from starting on trial to death from any cause. It also records adverse-event counts and names progression free survival and objective response rate as secondary outcomes.
What the posted information does not establish is the primary survival estimate. The median overall survival and its 95% confidence interval are not reported in the registry record. The secondary efficacy outcome results are also not reported in the registry record. Without those estimates, it is not possible to describe the observed magnitude or precision of the primary outcome from this record.
Nor does the design provide a randomized treatment comparison. A result observed in the group receiving the combination would describe that group, but it would not by itself establish what would have happened to a comparable group receiving another treatment or no study treatment. The record does not include a control arm or a comparative estimate.
The adverse-event figures give a descriptive account of recorded events in the treatment group. They should not be interpreted as proof that treatment caused any event, and the registry entries do not identify the 20 deaths as treatment-related. The serious-event terms and their reported percentages do not replace the primary survival analysis or define a treatment effect.
Overall, the record provides useful design and endpoint definitions, but the information available for this analysis is insufficient for a quantitative conclusion about overall survival or comparative effectiveness. That is a limitation of the reported record, not evidence for a particular clinical conclusion.
13. Why This Trial Matters Statistically
This trial illustrates why design and reporting context matter when reading clinical statistics. The record names a clinically important time-to-event endpoint, defines its event and time origin, and specifies a median with a 95% confidence interval. But without the median and interval, readers cannot judge the magnitude or precision of the survival estimate. An endpoint label is not itself an outcome result.
The single-group design also sets a clear boundary on interpretation. It can describe outcomes among people treated with TAS 102 and ramucirumab, but there is no concurrent randomized control group to support a direct treatment contrast. This distinction applies even when an outcome is clinically meaningful: descriptive outcome estimates and comparative treatment effects answer different questions.
The record further shows why adverse-event data need careful context. Counts and event-term percentages can describe what was recorded, but attribution, observation time, and participant-level detail affect their interpretation. The counts cannot be converted into a comparative safety conclusion without an appropriate comparator and compatible follow-up information.
Finally, planning calculations are conceptually distinct from trial design and trial findings. The posted planning assumptions refer to a hypothetical two-arm allocation and an effect based on an observed effect, whereas this study is recorded as single group. Those calculations are illustrations, not evidence of observed power and not proof of the study’s original sample-size rationale. Keeping these categories separate prevents planning assumptions from being mistaken for results.
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 specific to this record constrain interpretation. The primary endpoint is defined, but its median and 95% confidence interval are not reported in the registry record. Although the record lists a 6 months timeframe, it does not provide a follow-up summary or enough detail to determine how much observation contributed to the survival analysis.
The single-group design has no randomized comparator, so it cannot provide a like-for-like estimate of outcomes relative to another treatment. The allocation field is NA, the masking field is none, and the model is single group. The registry record does not describe a control regimen or comparative analysis.
The listed enrollment is 23, but the number included in each outcome analysis and the analysis populations are not reported in the registry record. The record does not specify censoring rules for overall survival, missing-data procedures, participant disposition, or the statistical analysis plan. The number of deaths in the adverse-event record does not substitute for an endpoint analysis, because the analysis population, timing, and survival estimate are not given.
Safety interpretation is limited by absent information on event attribution, timing, duration, and exposure. The record lists 7 participants with at least one serious adverse event, 23 with at least one other adverse event, and 20 deaths, but does not identify the deaths as treatment-related. It also does not clarify in the registry entries how event terms overlap at the participant level.
Finally, the registry names secondary outcomes but does not report their results in the registry record. It does not report a multiplicity strategy or interim analyses. These omissions limit reproducibility and prevent a full assessment of the study’s statistical evidence.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: TAS 102 in Combination With Ramucirumab in Advanced, Refractory Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma — NCT03686488.
- Registry record last updated 2026-03-02; status last verified 2026-02.
- Results first posted 2023-03-15.
- 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
NCT03686488 is a completed phase II, single-group study sponsored by H. Lee Moffitt Cancer Center and Research Institute. It evaluates TAS 102 administered concurrently with ramucirumab in advanced, refractory gastric or gastroesophageal junction adenocarcinoma. The registry lists enrollment of 23, a start date of 2018-12-20, and a primary completion date of 2022-01-19.
Overall survival is the primary outcome, defined as time from starting on trial to death from any cause, with a median and 95% confidence interval specified and a 6 months timeframe. The median and interval are not reported in the registry record. Named secondary outcomes are adverse events, progression free survival, and objective response rate. The record also reports adverse-event counts, but does not provide a randomized comparator or the detailed analysis methods needed for a comparative interpretation.