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NCT04150640 · ClinicalTrials.gov registry record · Phase 2
Oxaliplatin and Liposomal Irinotecan (Plus Trastuzumab for HER2-positive Disease) in Advanced Esophageal and Gastric Adenocarcinoma
A Phase 2 study of Gastric Adenocarcinoma and Esophageal Adenocarcinoma, sponsored by University of Wisconsin, Madison.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 52
- Enrollment target
- 1
- Study location
NCT04150640: Recruiting Phase 2 study of Gastric Adenocarcinoma and Esophageal Adenocarcinoma, sponsored by University of Wisconsin, Madison.
NCT04150640 is a Phase 2 study of Gastric Adenocarcinoma and Esophageal Adenocarcinoma that is actively recruiting participants, run by University of Wisconsin, Madison. The registered enrollment target is 52 participants, below the 244-participant average among 47 other Gastric Adenocarcinoma trials with a reported enrollment target (79% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04150640, a Phase 2 study of Gastric Adenocarcinoma and Esophageal Adenocarcinoma, is actively recruiting participants, sponsored by University of Wisconsin, Madison.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 52 participants
- Enrollment target
- 1
- Study location
Study Summary
This is an open label, phase II, multi-site trial evaluating the efficacy and safety of the combination of 5-FU, oxaliplatin, nal-IRI, and immunotherapy (plus trastuzumab for HER2-positive tumors) as first-line therapy for participants with advanced Esophageal and Gastric Adenocarcinoma (EGA). The investigators hypothesize that this drug combination will be better tolerated than current first-line chemotherapy combinations for this disease.
Primary Outcome
ORR will be calculated by combining the number of participants who achieve complete response and partial response per RECIST 1.1 criteria, from the start of treatment until disease progression/recurrence (taking as reference for progressive disease the smallest measurements recorded since the start of treatment). An ORR of 40% or less for proposed combination of 5-Fluorouracil, Oxaliplatin and nal-IRI during 1st line treatment of advanced esophageal and gastric adenocarcinoma in HER2-negative su
Conditions Studied
Interventions
- DRUG Pembrolizumab
- DRUG Trastuzumab
- DRUG Oxaliplatin
- DRUG 5-FU
- DRUG Nal-IRI
Study Locations (1)
Wisconsin
- University of Wisconsin Carbone Cancer Center - Madison
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 52 participants |
| Start Date | 2020-07-13 |
| Est. Completion | 2027-12 |
| Phase | Phase 2 |
What NCT04150640 shows while recruiting
NCT04150640 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 52 participants, a relatively small participant target, below the 244-participant average among 47 other Gastric Adenocarcinoma trials with a reported enrollment target (79% lower).
The record links to 2 conditions, with Gastric Adenocarcinoma appearing as the primary indexed condition, and to 5 interventions - of which Pembrolizumab is the first listed.
NCT04150640 reports a single indexed study location in Wisconsin.
Frequently Asked Questions
What is clinical trial NCT04150640 about?
NCT04150640 is a clinical study titled "Oxaliplatin and Liposomal Irinotecan (Plus Trastuzumab for HER2-positive Disease) in Advanced Esophageal and Gastric Adenocarcinoma". This is an open label, phase II, multi-site trial evaluating the efficacy and safety of the combination of 5-FU, oxaliplatin, nal-IRI, and immunotherapy (plus trastuzumab for HER2-positive tumors) as first-line therapy for participants with advanced Esophageal and Gastric Adenocarcinoma (EGA). The i...
What is the current status of trial NCT04150640?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 52 participants. The study started on 2020-07-13. Estimated completion is 2027-12.
What conditions does trial NCT04150640 study?
This clinical trial studies the following conditions: Gastric Adenocarcinoma, Esophageal Adenocarcinoma.
What interventions are being tested in trial NCT04150640?
The interventions under investigation include: Pembrolizumab (DRUG), Trastuzumab (DRUG), Oxaliplatin (DRUG), 5-FU (DRUG), Nal-IRI (DRUG).
Who is sponsoring clinical trial NCT04150640?
This trial is sponsored by University of Wisconsin, Madison, which has 1,039 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04150640 being conducted?
This trial has 1 study location across Wisconsin. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04150640's enrollment target sits among peer trials
52 27th of 47 higher than 20 of 47 other Gastric Adenocarcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Gastric Adenocarcinoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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