Trial · NCT03126435
EndoTAG-1+GEM vs GEM in Patients With Locally Advanced/Metastatic Pancreatic Adenocarcinoma Failed on FOLFIRINOX
NCT03126435, Phase 3, Completed, SynCore Biotechnology Co., Ltd.; results first posted 2023-03-24
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. EndoTAG-1+GEM vs GEM in Patients With Locally Advanced/Metastatic Pancreatic Adenocarcinoma Failed on FOLFIRINOX. Trials, record NCT03126435. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03126435
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- EndoTAG-1+GEM vs GEM in Patients With Locally Advanced/Metastatic Pancreatic Adenocarcinoma Failed on FOLFIRINOX
- NCT number
- NCT03126435
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 218 participants, actual
- Lead sponsor
- SynCore Biotechnology Co., Ltd.
- Conditions
- Metastatic Pancreas Cancer, Locally Advanced Pancreatic Cancer, Pancreatic Adenocarcinoma
- Interventions
- EndoTAG-1, Gemcitabine
- First posted
- 2017-04-24
- Last updated
- 2023-05-06
- Results first posted
- 2023-03-24
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Survival | From randomization to death from any cause or last day known to be alive, up to approximately 33.5 months (assessed continuously during treatment) | The efficacy of EndoTAG-1 treatment was demonstrated through number of events, meaning subject death, compared to number of subjects censored at the time of analysis. |
| Secondary | Progression Free Survival (PFS) | From randomization to either first observation of progressive disease or occurrence of death, up to approximately 33.5 months (assessed continuously during treatment) | The efficacy of EndoTAG-1 treatment was demonstrated through number of events, meaning first observation of progressive disease, compared to number of subjects censored at the time of analysis. |
| Secondary | Percentage of Subjects With Objective Response | Up to approximately 33.5 months (assessed continuously during treatment) | Percentage of subjects with objective response is based on assessment of complete response (CR) or partial response (PR) according to RECIST v.1.1. |
| Secondary | Duration of Response | From the first documentation of objective tumor response (date of the first CR or PR) to objective tumor progression or death due to any cause. | Duration of Response = (date of tumor progression or death - date of first objective response (CR or PR) +1) / 30. |
| Secondary | Percentage of Subjects With Disease Control According to RECIST v.1.1 | Up to approximately 33.5 months (assessed continuously during treatment) | Percentage of subjects with disease control is based on assessment of complete response (CR) or partial response (PR) or stable disease (SD) according to RECIST v.1.1 |
| Secondary | Serum Carcinoma Antigen 19-9 (CA 19-9) Response Rate | Up to approximately 33.5 months (assessed at baseline, end of cycle 1 or the full treatment course) | 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. |
| Other | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Up to approximately 33.5 months (assessed at baseline and end of treatment (EOT)) | European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) consists of 26 questions (Qs) relating to disease symptoms, treatment (Tx) side effects and emotional issues specific to pancreatic cancer (PC). Questions include on altered bowled habits, pain, dietary changes, disease and Tx-related symptoms and issues related to the emotional and social well-being of participants with PC. All 26 Qs are answered on 4-point Likert scale ranging from '1=not at all' to 4='very much' and subsequently transformed into scales that range from 0-100; higher scores= greater degree of symptoms or treatment side effects and emotional issues. |
| Other | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Up to approximately 33.5 months (assessed at baseline and end of treatment (EOT)) | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30): included functional scales (physical, role, cognitive, emotional, and social), global health status (GHS), symptom scales (fatigue, pain, nausea/ vomiting), and single items (dyspnoea, appetite loss, insomnia, constipation/diarrhea, and financial difficulties). Most questions used 4- point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores averaged, transformed to 0-100 scale; higher score = better level of functioning or greater degree of symptoms. Change from baseline = Cycle/day score minus baseline score. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Survival | From randomization to death from any cause or last day known to be alive, up to approximately 33.5 months (assessed continuously during treatment) | days | MEDIAN | |
| SECONDARY | Progression Free Survival (PFS) | From randomization to either first observation of progressive disease or occurrence of death, up to approximately 33.5 months (assessed continuously during treatment) | days | MEDIAN | |
| SECONDARY | Percentage of Subjects With Objective Response | Up to approximately 33.5 months (assessed continuously during treatment) | 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. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Duration of Response | From the first documentation of objective tumor response (date of the first CR or PR) to objective tumor progression or death due to any cause. | Months | MEAN | |
| SECONDARY | Percentage of Subjects With Disease Control According to RECIST v.1.1 | Up to approximately 33.5 months (assessed continuously during treatment) | There were 12 subjects in the EndoTAG-1 treated group and 22 subjects in the Gemcitabine Monotherapy group that were not included in analysis due to missing records. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Serum Carcinoma Antigen 19-9 (CA 19-9) Response Rate | Up to approximately 33.5 months (assessed at baseline, end of cycle 1 or the full treatment course) | Participants | COUNT_OF_PARTICIPANTS | |
| OTHER_PRE_SPECIFIED | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Up to approximately 33.5 months (assessed at baseline and end of treatment (EOT)) | Some missing data (Change from baseline is based on subjects with paired values.) | score on a scale | MEAN |
| OTHER_PRE_SPECIFIED | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Up to approximately 33.5 months (assessed at baseline and end of treatment (EOT)) | Some missing data (Change from baseline is based on subjects with paired values.) | score on a scale | MEAN |
Source ClinicalTrials.gov
Results by group58
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Survival | EndoTAG-1 and Gemcitabine | 226 | 95% Confidence Interval 183.0 to 278.0 | days | |
| Overall Survival | Gemcitabine Monotherapy | 209 | 95% Confidence Interval 158.0 to 248.0 | days | |
| Progression Free Survival (PFS) | EndoTAG-1 and Gemcitabine | 113 | 95% Confidence Interval 79.0 to 168.0 | days | |
| Progression Free Survival (PFS) | Gemcitabine Monotherapy | 110 | 95% Confidence Interval 60.0 to 115.0 | days | |
| Percentage of Subjects With Objective Response | EndoTAG-1 and Gemcitabine | 11 | Participants | ||
| Percentage of Subjects With Objective Response | Gemcitabine Monotherapy | 6 | Participants | ||
| Duration of Response | EndoTAG-1 and Gemcitabine | 5.8 | Standard Deviation 2.62 | Months | |
| Duration of Response | Gemcitabine Monotherapy | 9.1 | Standard Deviation 6.97 | Months | |
| Percentage of Subjects With Disease Control According to RECIST v.1.1 | EndoTAG-1 and Gemcitabine | 57 | Participants | ||
| Percentage of Subjects With Disease Control According to RECIST v.1.1 | Gemcitabine Monotherapy | 43 | Participants |
1 to 10 of 58Source ClinicalTrials.gov
See all 58 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | EndoTAG-1 and Gemcitabine | 108 | |
| Overall Study | STARTED | Gemcitabine Monotherapy | 110 | |
| Overall Study | COMPLETED | EndoTAG-1 and Gemcitabine | 2 | |
| Overall Study | COMPLETED | Gemcitabine Monotherapy | 6 | |
| Overall Study | NOT COMPLETED | EndoTAG-1 and Gemcitabine | 106 | |
| Overall Study | NOT COMPLETED | Gemcitabine Monotherapy | 104 |
Source ClinicalTrials.gov
Adverse events220
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Platelet Count Decreased | Investigations | EndoTAG-1 and Gemcitabine | 41 | 102 | 200 |
| other | Platelet Count Decreased | Investigations | Gemcitabine Monotherapy | 42 | 102 | 193 |
| other | Neutrophil Count Decreased | Investigations | EndoTAG-1 and Gemcitabine | 18 | 102 | 83 |
| other | Neutrophil Count Decreased | Investigations | Gemcitabine Monotherapy | 21 | 102 | 83 |
| other | White Blood Cell Count Decreased | Investigations | EndoTAG-1 and Gemcitabine | 18 | 102 | 58 |
| other | White Blood Cell Count Decreased | Investigations | Gemcitabine Monotherapy | 17 | 102 | 71 |
| other | Alanine Aminotransferase Increased | Investigations | EndoTAG-1 and Gemcitabine | 17 | 102 | 43 |
| other | Alanine Aminotransferase Increased | Investigations | Gemcitabine Monotherapy | 17 | 102 | 31 |
| other | Aspartate Aminotransferase Increased | Investigations | EndoTAG-1 and Gemcitabine | 14 | 102 | 30 |
| other | Aspartate Aminotransferase Increased | Investigations | Gemcitabine Monotherapy | 17 | 102 | 29 |
1 to 10 of 220Source ClinicalTrials.gov
See all 220 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | EndoTAG-1 and Gemcitabine | 91 | 108 |
| Total, all-cause mortality | Gemcitabine Monotherapy | 85 | 110 |
| Total, other adverse events | EndoTAG-1 and Gemcitabine | 101 | 102 |
| Total, other adverse events | Gemcitabine Monotherapy | 100 | 102 |
| Total, serious adverse events | EndoTAG-1 and Gemcitabine | 52 | 102 |
| Total, serious adverse events | Gemcitabine Monotherapy | 48 | 102 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons5
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| EndoTAG-1 and Gemcitabine vs Gemcitabine Monotherapy: Percentage of Subjects With Disease Control According to RECIST v.1.1 | Trial comparisons |
| EndoTAG-1 and Gemcitabine vs Gemcitabine Monotherapy: Percentage of Subjects With Objective Response | Trial comparisons |
| EndoTAG-1 and Gemcitabine vs Gemcitabine Monotherapy: Serum Carcinoma Antigen 19-9 (CA 19-9) Response Rate | Trial comparisons |
| EndoTAG-1 and Gemcitabine vs Gemcitabine Monotherapy: deaths from any cause | Trial comparisons |
| EndoTAG-1 and Gemcitabine vs Gemcitabine Monotherapy: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
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
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
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GET https://conductscience.org/api/trials/v1/NCT03126435/results?page=2