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 Nivolumab (Anti-PD1), Tadalafil and Oral Vancomycin in People With Refractory Primary Hepatocellular Carcinoma or Liver Dominant Metastatic Cancer From Colorectal or Pancreatic Cancers (NCT03785210), a na phase 2 study. The primary outcome is Best Overall Response (BOR).
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT03785210 |
| Phase | Phase 2 |
| Condition | Hepatocellular Carcinoma, Hepatocellular Cancer, Metastatic Pancreatic Cancer |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 22 |
| Arms in the primary outcome | n/a |
| Lead sponsor | National Cancer Institute (NCI) |
| Results posted | Yes |
2. Clinical Question
The study asked whether nivolumab given with tadalafil and oral vancomycin could produce tumor shrinkage in adults with refractory primary hepatocellular carcinoma or liver-dominant metastatic cancer from colorectal or pancreatic cancer. The registry defines tumor response using RECIST v1.1, with the best response recorded from treatment start until disease progression or recurrence. Although the study objective concerns shrinkage, the primary endpoint is best overall response, which also encompasses stable disease and progressive disease.
Population
Adults ages 18 years and older with hepatocellular carcinoma or liver metastases from colorectal or pancreatic cancer for which standard treatment had not worked. The trial enrolled 22 participants and distinguished a hepatocellular carcinoma cohort from a liver-metastases cohort.
Intervention
Nivolumab, tadalafil and oral vancomycin were administered together. Nivolumab was given by infusion on Day 1 of each 4-week cycle; tadalafil was taken daily by mouth. The registry describes oral vancomycin as daily during weeks 1 3, with no vancomycin during week 4.
Comparator
The study used a single-group model and lists no separate comparator group. Allocation is recorded as NA, and masking as none. The results therefore do not provide a randomized, like-for-like comparison against another treatment or control.
Primary question
What best overall response was recorded during treatment, assessed using RECIST v1.1? The registry defines complete response, partial response, stable disease and progressive disease, but the observed response counts are not reported in the registry record.
The study also listed serious adverse events and overall survival among its secondary outcomes. The registry describes follow-up for the primary outcome as occurring every 2 months and then every 6 months after treatment discontinuation, for survival purposes, up to 3 years. The results available in the record do not answer how the combination compared with another approach, nor do they give a reported primary-response estimate.
3. Trial Design
This was a phase II, single-group study sponsored by the National Cancer Institute (NCI). The registry lists an enrollment of 22 and identifies the intervention as the combination of nivolumab, tadalafil and oral vancomycin. The study is marked terminated. Its start date is 2019-06-05, and its primary completion date is 2022-10-31.
The record separates participants into a cohort with hepatocellular carcinoma and a cohort with liver metastases. It does not describe a randomized allocation: allocation is listed as NA, and masking is listed as none. With no separate control group, the design can describe outcomes among treated participants but cannot, by itself, estimate how those outcomes compare with a concurrent untreated or alternative-treatment group.
The registry describes treatment in 4-week cycles. Nivolumab was infused through a small plastic tube in the arm on Day 1. Tadalafil was taken orally daily. Oral vancomycin was taken orally four times a day, described as daily during weeks 1 3 and not taken during week 4. Participants were asked to keep a medicine diary recording dates, times, missed doses and symptoms. Screening and follow-up procedures included medical history, symptom and activity review, physical examination, heart testing, chest, abdomen and pelvis scans, blood and urine tests, review of a tumor sample, and stool samples or rectal swabs during the study.
The record describes a study intended to evaluate response and lists overall survival and serious adverse events among the secondary outcomes. The reasons for termination and the enrollment target rationale are not reported in the registry record. Details of any changes to the study conduct, treatment exposure, or follow-up after termination are also not reported in the registry record. Consequently, the listed design gives useful context for interpreting the intended evaluation, but it does not establish how completely the planned evaluations were carried out.
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 | Cohort 1, Arm 1, Treatment Assignment Code 1, Participants With Hepatocellular Carcinoma | Cohort 2, Arm 1, Treatment Assignment Code 1, Participants With Liver Metastases |
|---|---|---|
| STARTED | 6 | 16 |
| COMPLETED | 5 | 10 |
| NOT COMPLETED | 1 | 6 |
Reasons for not completing this period:
| Reason | Cohort 1, Arm 1, Treatment Assignment Code 1, Participants With Hepatocellular Carcinoma | Cohort 2, Arm 1, Treatment Assignment Code 1, Participants With Liver Metastases |
|---|---|---|
| Principal investigator decision - clinical progression | 1 | 6 |
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 | Cohort 1, Arm 1, Treatment Assignment Code 1, Participants With Hepatocellular Carcinoma | Cohort 2, Arm 1, Treatment Assignment Code 1, Participants With Liver Metastases | Total |
|---|---|---|---|---|
| Participants analysed | 6 | 16 | 22 | |
| Age, Categorical: <=18 years | Participants | 0 | 0 | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 1 | 11 | 12 |
| Age, Categorical: >=65 years | Participants | 5 | 5 | 10 |
| Age, Continuous | years | 69.08 (SD 8.15) | 63.61 (SD 11.52) | 65.1 (SD 10.81) |
| Sex: Female, Male: Female | Participants | 1 | 5 | 6 |
| Sex: Female, Male: Male | Participants | 5 | 11 | 16 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 2 | 0 | 2 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 4 | 16 | 20 |
| 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 | 1 | 1 | 2 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Black or African American | Participants | 2 | 5 | 7 |
| Race (NIH/OMB): White | Participants | 1 | 10 | 11 |
| Race (NIH/OMB): More than one race | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 2 | 0 | 2 |
| Region of Enrollment: United States | participants | 6 | 16 | 22 |
6. Primary Endpoint
The registry lists the primary outcome as Best Overall Response (BOR), measured over Every 2 months and then every 6 months after discontinuation of treatment, for survival purposes, up to 3 years.
| Element | Registry entry |
|---|---|
| Result type | Count Of Participants |
| Measure of spread | not applicable |
| Unit | Participants |
| Endpoint classification | Binary Endpoint |
The primary endpoint is best overall response, reported as a count of participants. Best overall response is the best response recorded from treatment start until disease progression or recurrence, using RECIST v1.1. The registry describes complete response as disappearance of all target lesions. Partial response requires at least a 30% decrease in the sum of target-lesion diameters from baseline. Progressive disease is defined as at least a 20% increase from the smallest sum recorded on study, or the appearance of one or more new lesions. Stable disease is neither enough shrinkage for partial response nor enough increase for progressive disease, using the smallest sum recorded while on study as the reference.
Best overall response is used to characterize tumor status over an assessment period, rather than relying on a single scan. In general, combining serial assessments into a best recorded response can distinguish tumor shrinkage from stability or progression. The category definitions matter because a response count depends on the assessment rules, the timing of imaging and the availability of evaluable scans.
The registry specifies the endpoint definition and assessment framework, but the observed response counts and any response estimate are not reported in the registry record. The record also does not report how many participants had an evaluable response assessment, how missing scans were handled, or whether any response categories were combined for analysis. Without those details, the endpoint can be described, but its observed distribution and precision cannot be evaluated from the record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record identifies best overall response as the primary endpoint and gives a detailed RECIST v1.1 definition. However, it does not report the number of participants in each response category, an overall response estimate, or an interval describing uncertainty around that estimate. As a result, the primary endpoint cannot be quantitatively interpreted from the registry record. The stated study objective concerns tumor shrinkage, but no shrinkage result is reported in the registry record.
The design is important to interpretation. This is a single-group study with no listed comparator and no masking. Outcomes among participants receiving the combination may be described, but they cannot establish how the combination compares with another treatment or what would have happened to similar participants without it. Differences between the two cancer cohorts would also not be randomized comparisons; the cohorts represent different disease groups.
The study status is terminated. That status does not, by itself, explain why the study ended or whether the reason was related to efficacy, safety, recruitment, operational issues, or another cause. The reason for termination is not reported in the registry record. Nor does the record report whether all planned assessments were completed. The listed enrollment is 22, but the number with a reported primary endpoint result is not reported in the registry record.
Safety information is present for the two cohorts. The record lists serious events affecting 2 of 6 participants in the hepatocellular carcinoma cohort and 7 of 16 participants in the liver-metastases cohort. It separately lists other adverse events affecting 6 of 6 and 16 of 16 participants, respectively, and deaths of 5 and 15. These are descriptive counts in the registry record. They do not establish that the treatment caused the events or deaths, and the record does not give timing, duration, severity grading, or individual-level overlap among events.
The posted information therefore supports a description of the intended clinical question, the response criteria, the single-group design and selected safety counts. It does not support a conclusion about the frequency of response, comparative benefit, or the precision of a treatment effect. Any confidence interval, hypothesis test or analysis-adjusted estimate for the primary endpoint is not reported in the registry record. Those omissions limit what can be inferred from the posted results, independently of the endpoint definition.
9. Statistical Methods Explained
The registry defines a count endpoint: best overall response is recorded in participants, with response classification governed by RECIST v1.1. The record lists no analyses for the primary outcome. It therefore offers a planned endpoint definition, but not a reported inferential analysis from which to judge the observed response distribution or its uncertainty.
What does a best overall response measure?
In general, a best overall response summarizes the most favorable recorded disease status during the specified assessment period. That summary differs from a measurement at a single visit: it uses the sequence of assessments to identify the best category reached before progression or recurrence. RECIST v1.1 sets thresholds and rules for classifying changes in target-lesion measurements and for recognizing new lesions. In this registry record, complete response means disappearance of all target lesions; partial response requires at least a 30% decrease in their summed diameters relative to baseline; and progressive disease includes at least a 20% increase from the smallest on-study sum or the appearance of new lesions. Stable disease falls between the stated shrinkage and progression criteria.
These categories are not interchangeable. A count of participants with complete response is different from a count with partial response, and neither is identical to a count with stable disease. The primary endpoint is specified as best overall response, but the registry record does not report category counts or say that categories were combined into a single binary outcome. A response proportion or other summary cannot be reconstructed without the relevant observed counts and analysis definition.
What does uncertainty mean for a count?
In general, a confidence interval expresses the range of values compatible with the observed data under a specified statistical model and procedure. It helps distinguish a precise estimate from one that remains uncertain. For a response proportion, the width of an interval is influenced by the number of evaluable participants and the observed response frequency. This is a general statistical point, not a reported analysis for this study: no primary-response estimate or confidence interval is reported in the registry record.
A hypothesis test, if used, would address a stated comparison or reference value. The registry record does not report such a reference value, a primary-outcome hypothesis test, or a statistical analysis plan. A p-value cannot be inferred from the endpoint definition or the enrollment figure alone. The registry lists zero analyses, so there is no posted primary analysis to interpret alongside the endpoint.
Why does the single-group design matter?
In general, a single-group study describes outcomes in participants receiving the study intervention. Without a concurrent comparison group, changes observed during treatment cannot separate an intervention effect from other explanations, such as the natural course of disease, prior treatment history, participant selection, or changes in care. These are general design considerations; the record does not quantify their contribution in this study. A single-group design can still provide descriptive information, but it does not yield a randomized estimate of a treatment difference.
The two cohorts are defined by disease type: hepatocellular carcinoma and liver metastases. Because the registry identifies them as cohorts within the same single-group study, their outcome counts should not be interpreted as a randomized treatment contrast. The diseases and participant characteristics may differ, and the record does not provide adjusted analyses that would address those differences.
What can the safety counts establish?
Counts of participants with events are descriptive. They can indicate how many participants in a recorded cohort had an event, but they do not by themselves show when events occurred, whether the same participant had multiple events, or whether an event was caused by treatment. In general, an event rate requires a clearly defined denominator and observation period; a comparison of rates also requires comparable definitions and follow-up. The serious-event counts in the record are not accompanied by person-time, detailed event-level data, or a control group.
The record names serious adverse events possibly, probably, and/or definitely related to treatment as a secondary outcome, but it does not report a complete analysis of that outcome. The available cohort counts and listed serious-event terms should therefore be read as descriptive registry entries, not as adjusted causal estimates. A complete statistical interpretation would require the outcome definitions, analysis population, handling of incomplete observation and the relevant uncertainty estimates. These details are not reported in the registry record.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists four outcome measures and identifies best overall response as the primary outcome. It also names serious adverse events possibly, probably, and/or definitely related to treatment and overall survival among secondary outcomes. The record does not provide a multiplicity strategy describing how inference across outcomes or response categories would be controlled. Any adjustment, hierarchy, or prespecified prioritization beyond the primary designation is not reported in the registry record.
Missing-data handling for the primary endpoint is not reported in the registry record. In particular, the record does not say how participants without a post-baseline scan, with an incomplete assessment, or with early discontinuation were classified or included. It also does not report the number of participants evaluable for response. The enrollment figure alone does not establish the analysis population for this endpoint.
The record does not describe an intention-to-treat, per-protocol, safety, or other analysis population for the primary response result. It does not report how participants were handled if treatment stopped before a response assessment, or how missing survival follow-up was treated. These population definitions and rules are not reported in the registry record.
The registry lists zero analyses, and the primary response counts and inferential results are not reported in the registry record. Statistical methods such as confidence interval construction, hypothesis testing, adjustment for covariates, or sensitivity analysis are not described. The record also does not state whether interim analyses occurred. Consequently, readers cannot determine from the posted information how multiplicity or incomplete endpoint data may have affected the intended or observed analyses.
These omissions do not establish that a particular method was or was not used; they mean that the method is not documented in the registry record. They limit reproducibility and make it impossible to assess whether any reported estimates, if generated outside the posted record, follow prespecified analysis rules.
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 |
|---|---|---|---|
| Cohort 1, Arm 1, Treatment Assignment Code 1, Participants With Hepatocellular Carcinoma | 2 | 6 | 33.3% |
| Cohort 2, Arm 1, Treatment Assignment Code 1, Participants With Liver Metastases | 7 | 16 | 43.8% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Cohort 1, Arm 1, Treatment Assignment Code 1, Participants With Hepatocellular Carcinoma | 5 of 6 |
| Cohort 2, Arm 1, Treatment Assignment Code 1, Participants With Liver Metastases | 15 of 16 |
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 |
|---|---|
| Cohort 1, Arm 1, Treatment Assignment Code 1, Participants With Hepatocellular Carcinoma | 6 of 6 |
| Cohort 2, Arm 1, Treatment Assignment Code 1, Participants With Liver Metastases | 16 of 16 |
Most frequent serious adverse event terms
| Event term | Organ system | Cohort 1, Arm 1, Treatment Assignment Code 1, Participants With Hepatocellular Carcinoma | Cohort 2, Arm 1, Treatment Assignment Code 1, Participants With Liver Metastases |
|---|---|---|---|
| Thromboembolic event | Vascular disorders | 1 of 6 | 2 of 16 |
| Abdominal pain | Gastrointestinal disorders | 0 of 6 | 2 of 16 |
| Ascites | Gastrointestinal disorders | 0 of 6 | 2 of 16 |
| Fever | General disorders | 1 of 6 | 1 of 16 |
| Back pain | Musculoskeletal and connective tissue disorders | 0 of 6 | 1 of 16 |
| Blood bilirubin increased | Investigations | 0 of 6 | 1 of 16 |
| Colonic perforation | Gastrointestinal disorders | 0 of 6 | 1 of 16 |
| Diarrhea | Gastrointestinal disorders | 0 of 6 | 1 of 16 |
| Disease progression | General disorders | 0 of 6 | 1 of 16 |
| Duodenal obstruction | Gastrointestinal disorders | 0 of 6 | 1 of 16 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Cohort 1, Arm 1, Treatment Assignment Code 1, Participants With Hepatocellular Carcinoma | Cohort 2, Arm 1, Treatment Assignment Code 1, Participants With Liver Metastases |
|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | 5 of 6 | 12 of 16 |
| Lymphocyte count decreased | Investigations | 3 of 6 | 9 of 16 |
| Hypoalbuminemia | Metabolism and nutrition disorders | 2 of 6 | 9 of 16 |
| Fatigue | General disorders | 1 of 6 | 9 of 16 |
| Hyponatremia | Metabolism and nutrition disorders | 3 of 6 | 7 of 16 |
| Hypokalemia | Metabolism and nutrition disorders | 2 of 6 | 7 of 16 |
| Constipation | Gastrointestinal disorders | 2 of 6 | 6 of 16 |
| Aspartate aminotransferase increased | Investigations | 0 of 6 | 7 of 16 |
| Platelet count decreased | Investigations | 4 of 6 | 3 of 16 |
| Abdominal pain | Gastrointestinal disorders | 1 of 6 | 5 of 16 |
Serious events with the highest arm-level rate: fever (16.7%), thromboembolic event (16.7%), abdominal pain (12.5%), ascites (12.5%), back pain (6.2%).
The registry records two cohorts for adverse events. In the hepatocellular carcinoma cohort, serious adverse events affected 2 of 6 participants at risk; other adverse events affected 6 of 6, and the record lists 5 deaths. In the liver-metastases cohort, serious adverse events affected 7 of 16 participants at risk; other adverse events affected 16 of 16, and the record lists 15 deaths. These are cohort-level counts as entered in the registry, not comparisons with an untreated or alternative-treatment group.
The listed serious-event terms include fever and thromboembolic event, each recorded as 16.7%; abdominal pain and ascites, each recorded as 12.5%; and back pain and blood bilirubin increased, each recorded as 6.2%. The registry does not give the denominator or event-level detail for interpreting each listed percentage. These terms should not be added together: a participant may have more than one event, and the record does not report whether categories overlap.
Counts of affected participants do not establish causation. Although a secondary outcome refers to serious events possibly, probably, and/or definitely related to treatment, the record does not provide event timing, severity grades, duration, detailed attribution, or cohort-specific follow-up time. Death counts also do not identify causes. The figures are useful as descriptive safety entries, but they do not support a controlled estimate of treatment-related risk.
12. What the Result Does, and Does Not, Mean
The registry record establishes the study question and the framework used to assess response. It describes a combination of nivolumab, tadalafil and oral vancomycin in adults with refractory hepatocellular carcinoma or liver-dominant metastatic cancer from colorectal or pancreatic cancer. It also defines best overall response using RECIST v1.1. These details explain what the investigators intended to measure and how response categories were defined.
The record does not report the primary response counts or an estimate of best overall response. It therefore cannot show how many participants had complete response, partial response, stable disease or progressive disease, nor how precise any response estimate would be. The absence of these results from the registry record should not be interpreted as evidence that no responses occurred or that a particular response category predominated.
The study's single-group design also limits interpretation. It can describe outcomes among participants who received the combination, but cannot provide a randomized comparison with another treatment. Observed events or changes cannot be attributed to the combination from this design alone. The separate disease cohorts are not randomized comparators, and the record does not report adjusted comparisons between them.
Safety counts are reported, including serious adverse events, other adverse events and deaths. Those figures describe entries for the two cohorts; they do not establish treatment causation, comparative safety, or the circumstances surrounding each event. The registry does not report detailed timing, individual overlap, or causes of death.
The record identifies the study as terminated but does not report the reason. It also does not document the primary analysis population, missing-data rules, uncertainty estimates, or multiplicity strategy. These limitations mean the posted record supports a description of design and some safety observations, rather than a quantitative conclusion about efficacy or a comparative treatment effect. Further claims about response, precision, or why the trial ended are not reported in the registry record.
13. Why This Trial Matters Statistically
This trial is statistically informative as an example of the distinction between a clearly defined endpoint and a reported endpoint result. The registry specifies best overall response, the RECIST v1.1 rules, and an assessment timeframe. Yet the response counts and statistical analyses are not reported in the registry record. A detailed definition is essential for consistent measurement, but it cannot substitute for observed data when estimating response or uncertainty.
The single-group design also makes the target of inference important. Descriptive outcomes among participants treated with the combination are not the same as a treatment effect relative to a comparator. Without randomized allocation or a listed control group, comparisons with external expectations would require additional assumptions and information that are not reported in the registry record. The two disease cohorts likewise should be read as clinical subgroups, not treatment arms in a randomized contrast.
The record additionally illustrates why safety counts need their context. Cohort counts can document how many participants were recorded with events, but event attribution, observation time, overlap and comparison data affect what those counts mean. The adverse-event entries do not resolve causality or comparative risk.
Finally, termination status and incomplete statistical reporting are relevant to transparency. The registry identifies the study as terminated, but does not state why. It lists outcomes, but does not report the primary response analysis, missing-data handling, analysis populations or multiplicity approach. Those are not merely technical details: they determine which participants contribute to an estimate and how uncertainty is characterized. Here, the statistical record supports careful description of the design and endpoint, while leaving the central response result unreported.
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.
The most direct limitation is that the registry record does not report the primary endpoint results. It gives the RECIST v1.1 definition of best overall response, but not category counts, an overall response estimate, or a measure of precision. It is therefore not possible to assess the primary outcome quantitatively from the record.
The study has a single-group, unmasked design and no listed comparator. This prevents a randomized comparison and limits interpretation to descriptive outcomes among participants receiving the combination. The record's two disease cohorts are not interchangeable populations and do not serve as randomized control groups.
The study is marked terminated, but the reason for termination is not reported in the registry record. The record does not explain whether enrollment and follow-up proceeded as planned or whether the planned primary assessments were completed. Although enrollment is listed as 22, the number included in an endpoint analysis is not reported in the registry record.
Analysis details are also limited. The record does not report how missing scans or incomplete assessments were handled, which participants formed the analysis population, how uncertainty was estimated, or whether analyses were adjusted for any covariates. A multiplicity strategy and details of interim analyses are not reported in the registry record.
The safety entries lack event-level context, including timing, severity grading, duration, participant overlap and detailed attribution. The listed death counts do not include causes. Follow-up duration for the adverse-event counts and the exposure time underlying them are not reported in the registry record. These limits mean the safety counts cannot be converted into a comparative or causal assessment. Together, the missing response results and methodological details substantially restrict conclusions from the posted record.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Nivolumab (Anti-PD1), Tadalafil and Oral Vancomycin in People With Refractory Primary Hepatocellular Carcinoma or Liver Dominant Metastatic Cancer From Colorectal or Pancreatic Cancers — NCT03785210.
- Registry record last updated 2026-02-23; status last verified 2026-02.
- Results first posted 2023-07-11.
- 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
NCT03785210 is a phase II, single-group study sponsored by the National Cancer Institute (NCI), evaluating nivolumab, tadalafil and oral vancomycin in adults with refractory hepatocellular carcinoma or liver-dominant metastases from colorectal or pancreatic cancer. The registry lists enrollment of 22, no masking, and a terminated status. The start date is 2019-06-05, and the primary completion date is 2022-10-31.
Best overall response by RECIST v1.1 is the primary endpoint. The registry defines response categories but does not report the observed response results or an analysis. Cohort-level adverse-event counts are listed, but the record does not provide enough detail to establish causation or comparative risk. The reason for termination, missing-data methods, analysis populations and multiplicity approach are not reported in the registry record.