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Phase 1
Phase 2
Age: 18Years +
All Genders
ID06384560

Neoadjuvant Chemotherapy, Immunotherapy, and Radiotherapy Followed by Surgery for Borderline Resectable Pancreatic Cancer

Led by Amsterdam UMC, location VUmc · Updated on 2026-02-13

66

Participants Needed

4

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating a new treatment approach for patients with borderline resectable pancreatic cancer, who generally face a limited life expectancy. The study aims to investigate whether combining chemotherapy, immunotherapy, and stereotactic radiotherapy before surgery, followed by additional treatments after surgery, improves survival outcomes. Participants will start with four cycles of modified FOLFIRINOX chemotherapy every two weeks. Pembrolizumab immunotherapy is given every six weeks, starting with the second chemotherapy cycle. After initial treatment, patients undergo restaging with scans and tumor markers. Those with stable or responding disease receive stereotactic radiotherapy over five sessions on non-consecutive days, followed by four more cycles of chemotherapy and immunotherapy. Surgery occurs 3 to 6 weeks after chemotherapy if the disease remains suitable for removal. After surgery, patients receive four cycles of chemotherapy plus five cycles of immunotherapy every six weeks. During the study, participants have regular assessments including CT scans and tumor marker tests to monitor their disease. Researchers measure survival without disease progression one year after treatment begins. Safety, treatment response, and overall health are closely monitored throughout. Participants involvement spans from initial treatment through surgery and subsequent therapies, with follow-up continuing to evaluate outcomes over time.

CONDITIONS

Brief Title

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

Research Team

J

J. W. Wilmink, MD, PhD

A

A. M. Gehrels, MD, MA

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