RecruitingPhase 1Phase 2NCT06384560

Neoadjuvant Triple Therapy for (Borderline) Resectable Pancreatic Cancer (PREOPANC-5)

Neoadjuvant Triple Treatment With mFOLFIRINOX, Pembrolizumab and SABR in Patients With (Borderline) Resectable Pancreatic Cancer (PREOPANC-5): a Multicenter Single Arm Phase Ib/II Trial of the Dutch Pancreatic Cancer Group

Sponsor

Amsterdam UMC, location VUmc

Enrollment

66 participants

Start Date

Sep 23, 2024

Study Type

INTERVENTIONAL

Conditions

Borderline Resectable Pancreatic Adenocarcinoma Resectable Pancreatic Adenocarcinoma Localized Pancreatic Adenocarcinoma

Summary

Since patients with (borderline) resectable pancreatic cancer have a limited life expectancy, it is important to improve treatment strategies. Therefore, the objective of this study is to investigate whether neoadjuvant triple treatment with chemotherapy (mFOLFIRINOX), immunotherapy (pembrolizumab and stereotactic radiotherapy, followed by adjuvant surgery and chemotherapy and immunotherapy, improves survival in patients with (borderline) resectabel pancreatic cancer.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This Dutch study (PREOPANC-5) is testing a three-drug combination approach — chemotherapy, radiation, and immunotherapy (pembrolizumab) — given before surgery to improve outcomes for patients with pancreatic cancer that may be operable. **You may be eligible if...** - You are 18 or older - You have confirmed pancreatic adenocarcinoma (the most common type) - Your cancer is resectable or borderline resectable (potentially removable with surgery) - You are healthy enough to undergo all three treatment types - Your blood counts, kidney, and liver function meet required levels **You may NOT be eligible if...** - Your cancer has already spread to other organs - You have previously received immunotherapy or chemotherapy for pancreatic cancer - You have active autoimmune disease or are on immune-suppressing drugs - You have active hepatitis B or C - You are pregnant or breastfeeding - You cannot have an MRI (if treated at certain centers) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPembrolizumab

Pembrolizumab 400 mg will be administered as a 30 minute IV infusion every 6 weeks.

DRUGFolfirinox

FOLFIRINOX is a combination of systemic chemotherapy agents. FOLFIRINOX consists of oxaliplatin at a dose of 85 mg/m2, given as a 2-hour intravenous infusion, immediately followed by leucovorin at a dose of 400 mg/m2 given as a 2-hour intravenous infusion, with the addition, after 30 minutes, of irinotecan at a dose of 150 mg/m2, given as a 90-minute intravenous infusion through a Y-connector. This treatment is followed by a continuous intravenous infusion of 2400 mg/m2 5-FU over a 46-hour period every 2 weeks. (The FOLFIRINOX given in the trial is the modified scheme, whereby the fluorouracil bolus at a dose of 400 mg/m2 is omitted and the irinotecan dose reduced to 150 mg/m2).

RADIATIONSABR

SABR will be delivered in an image-guided hypofractionated scheme of 5 fractions of 8 Gy (total 40 Gy), prescribed to 95% of the planning target volume (PTV). Treatment is delivered on five non-consecutive days.