FOLFIRINOX and Pembrolizumab for Resectable Pancreatic Cancer
This study is looking at whether combining chemotherapy (FOLFIRINOX) with an immunotherapy drug (pembrolizumab) before surgery can improve outcomes for people with pancreatic cancer that can be removed with surgery. Researchers want to see if this combination improves the overall response rate (how well the cancer shrinks or disappears) over three years. You might be able to join if you are 18 or older and have localized pancreatic adenocarcinoma that doctors believe can be surgically removed. The study aims to enroll 30 participants. The current recruitment status is unclear.
- Study design
- This is a Phase II interventional study involving 30 participants. All participants will receive the same treatment combination.
- What's involved
- You would receive 6 cycles of FOLFIRINOX chemotherapy and 2 cycles of pembrolizumab before surgery. After surgery, you would receive additional chemotherapy and 7 more cycles of pembrolizumab, for a total treatment duration of about 16 months.
- Compensation
- Not stated in the trial record.
- Follow-up
- The study will measure outcomes for three years after treatment to see if the overall response rate improves.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Neoadjuvant Folfirinox Combined With Pembrolizumab Followed by Surgery for Patients With Resectable Pancreatic Cancer
At a glance
Conditions
NCT05132504
Where you'd take part
This study runs at 3 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Baylor College of Medicine
Houston, Texasstudy coordinator listed
Recruiting
Baylor St. Luke's Medical Center (BSLMC).
Houston, Texasstudy coordinator listed
Recruiting
Houston Methodist Hospital
Houston, Texasstudy coordinator listed
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Ernest R. Camp, M.D., M.S.C.R., F.A.C.S. · PRINCIPAL_INVESTIGATOR · Baylor College of Medicine
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
What this trial measures
- Determine if the neoadjuvant FOLFIRINOX chemotherapy followed by pembrolizumab followed by surgery will improve the overall response rate (ORR) for patients with localized, resectable adenocarcinoma of the pancreas.3 years
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.