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NCT05132504 · ClinicalTrials.gov registry record · Phase 2
Neoadjuvant Folfirinox Combined With Pembrolizumab Followed by Surgery for Patients With Resectable Pancreatic Cancer
A Phase 2 study of Pancreatic Ductal Adenocarcinoma, sponsored by Baylor College of Medicine.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 30
- Enrollment target
- 3
- Study locations
NCT05132504: Recruiting Phase 2 study of Pancreatic Ductal Adenocarcinoma, sponsored by Baylor College of Medicine.
NCT05132504 is a Phase 2 study of Pancreatic Ductal Adenocarcinoma that is actively recruiting participants, run by Baylor College of Medicine. The registered enrollment target is 30 participants, below the 600-participant average among 84 other Pancreatic Ductal Adenocarcinoma trials with a reported enrollment target (95% lower). The trial reports 3 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05132504, a Phase 2 study of Pancreatic Ductal Adenocarcinoma, is actively recruiting participants, sponsored by Baylor College of Medicine.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 30 participants
- Enrollment target
- 3
- Study locations
Study Summary
Abbreviated Title: Neoadjuvant FOLFIRINOX combined with Pembrolizumab followed by surgery for patients with resectable pancreatic cancer Trial Phase: Phase II Clinical Indication: Pancreatic ductal adenocarcinoma; Adenocarcinoma; AJCC I, II, or III; 1st Line neoadjuvant Trial Type: Interventional prospective Type of control: Historical Route of administration: IV Treatment Groups: Neoadjuvant FOLFIRINOX combined with Pembrolizumab followed by surgery for patients with resectable pancreatic cancer Number of trial participants: 30 Estimated enrollment period: 24 months Estimated duration of trial: 3.5 Years Duration of Participation:16 months Estimated average length of treatment per patient: 16 months
Primary Outcome
The primary endpoints are overall response rate (ORR) defined as the proportion of patients with pathologic CR or PR. The primary analysis will compare the observed ORR to the null proportion of 5% using an exact binomial test. In addition, the percentage of ORR for the intervention with its 95% confidence interval will be presented.
Conditions Studied
Interventions
- DRUG Pembrolizumab
- DRUG Folfirinox
Study Locations (3)
Texas
- Baylor College of Medicine - Houston
- Baylor St. Luke's Medical Center (BSLMC). - Houston
- Houston Methodist Hospital - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2022-08-31 |
| Est. Completion | 2027-05-21 |
| Phase | Phase 2 |
What NCT05132504 shows while recruiting
NCT05132504 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 600-participant average among 84 other Pancreatic Ductal Adenocarcinoma trials with a reported enrollment target (95% lower).
The record links to 1 condition, with Pancreatic Ductal Adenocarcinoma appearing as the primary indexed condition, and to 2 interventions - of which Pembrolizumab is the first listed.
NCT05132504 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT05132504 about?
NCT05132504 is a clinical study titled "Neoadjuvant Folfirinox Combined With Pembrolizumab Followed by Surgery for Patients With Resectable Pancreatic Cancer". Abbreviated Title: Neoadjuvant FOLFIRINOX combined with Pembrolizumab followed by surgery for patients with resectable pancreatic cancer Trial Phase: Phase II Clinical Indication: Pancreatic ductal adenocarcinoma; Adenocarcinoma; AJCC I, II, or III; 1st Line neoadjuvant Trial Type: Interventional pr...
What is the current status of trial NCT05132504?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 30 participants. The study started on 2022-08-31. Estimated completion is 2027-05-21.
What conditions does trial NCT05132504 study?
This clinical trial studies the following conditions: Pancreatic Ductal Adenocarcinoma.
What interventions are being tested in trial NCT05132504?
The interventions under investigation include: Pembrolizumab (DRUG), Folfirinox (DRUG).
Who is sponsoring clinical trial NCT05132504?
This trial is sponsored by Baylor College of Medicine, which has 616 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05132504 being conducted?
This trial has 3 study locations across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05132504's enrollment target sits among peer trials
30 63rd of 84 higher than 20 of 84 other Pancreatic Ductal Adenocarcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Pancreatic Ductal 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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