Comparison · NCT03126435-58c5038f
EndoTAG-1 and Gemcitabine vs Gemcitabine Monotherapy: Percentage of Subjects With Objective Response
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
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ConductScience Library. EndoTAG-1 and Gemcitabine vs Gemcitabine Monotherapy: Percentage of Subjects With Objective Response. Trial comparisons, record NCT03126435-58c5038f. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03126435-58c5038f
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.115 | 0.0652 | 0.194 | wilson | |
| Risk in group 2 | 0.0682 | 0.0316 | 0.141 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0464 | -0.0415 | 0.133 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.68 | 0.649 | 4.35 | log | |
| Odds ratio, group 1 over group 2 | 1.77 | 0.625 | 5 | log | |
| Number needed to treat, for one more participant with the outcome on EndoTAG-1 and Gemcitabine than on Gemcitabine Monotherapy | 21.6 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | EndoTAG-1 and Gemcitabine | EndoTAG-1 22 mg/m² twice weekly plus Gemcitabine 1000 mg/m² once weekly for 1 cycle (8 weeks) consisting of 3 weeks of treatment and 1 week rest followed by 3 weeks of treatment and 1 week rest until any one of the following occurs: progressive disease or unacceptable toxicity or withdrawal of consent. | 11 | 96 | OG000 |
| Group 2 | Gemcitabine Monotherapy | Gemcitabine 1000 mg/m² once weekly, for 1 cycle (8 weeks) consisting of 3 weeks of treatment and 1 week rest followed by 3 weeks of treatment and 1 week rest until any one of the following occurs: progressive disease or unacceptable toxicity or withdrawal of consent.~Gemcitabine: once weekly | 6 | 88 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Percentage of Subjects With Objective Response
- Description
- Percentage of subjects with objective response is based on assessment of complete response (CR) or partial response (PR) according to RECIST v.1.1.
- Time frame
- Up to approximately 33.5 months (assessed continuously during treatment)
- Population
Of the 108 subjects that received EndoTAG-1 and Gemcitabine, 11 subjects (11.46%, 11/96) presented with a complete or partial response. There were 6 subjects (6.82%, 6/88) that received Gemcitabine Monotherapy considered to have an objective response. For 12 subjects in the EndoTAG-1 group and 22 subjects in the Gemcitabine Monotherapy group, objective response assessments were missing.
Source ClinicalTrials.gov
Trial
- Title
- EndoTAG-1+GEM vs GEM in Patients With Locally Advanced/Metastatic Pancreatic Adenocarcinoma Failed on FOLFIRINOX
- NCT number
- NCT03126435
- Phases
- PHASE3
- Conditions
- Metastatic Pancreas Cancer, Locally Advanced Pancreatic Cancer, Pancreatic Adenocarcinoma
- Interventions
- EndoTAG-1, Gemcitabine
- Lead sponsor
- SynCore Biotechnology Co., Ltd.
- Results first posted
- 2023-03-24
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03126435?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
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