Comparison · NCT03126435-90569893
EndoTAG-1 and Gemcitabine vs Gemcitabine Monotherapy: Serum Carcinoma Antigen 19-9 (CA 19-9) Response Rate
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: Serum Carcinoma Antigen 19-9 (CA 19-9) Response Rate. Trial comparisons, record NCT03126435-90569893. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03126435-90569893
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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 | 0.0185 | 0.00509 | 0.065 | wilson | |
| Risk in group 2 | 0.0182 | 0.005 | 0.0639 | wilson | |
| Risk difference, group 1 minus group 2 | 0.000337 | -0.0473 | 0.0487 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.02 | 0.146 | 7.1 | log | |
| Odds ratio, group 1 over group 2 | 1.02 | 0.141 | 7.37 | log | |
| Number needed to treat, for one more participant with the outcome on EndoTAG-1 and Gemcitabine than on Gemcitabine Monotherapy | 2,970 | 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.~EndoTAG-1: twice weekly~Gemcitabine: once weekly | 2 | 108 | 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 | 2 | 110 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Serum Carcinoma Antigen 19-9 (CA 19-9) Response Rate
- Description
Responders are defined as subjects with a reduction in CA 19-9 levels by least 50% from baseline to the end of cycle 1 (or end of full treatment course). If a subject died while on study, he/she was classified as a failure, regardless of previous assessments.
- Time frame
- Up to approximately 33.5 months (assessed at baseline, end of cycle 1 or the full treatment course)
- Population
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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