drugset / Trial / NCT07469956

Surufatinib Plus mFOLFIRINOX and PD-1 Inhibitor as the Neoadjuvant Therapy for High-risk or Borderline Resectable Pancreatic Cancer

NCT07469956

Phase 2 Not yet recruiting 30 enrolled Sun Yat-sen University
NaSingle-groupOpen-labelTreatment

Summary

The goal of this clinical trial is to learn if surufatinib (VEGFR-TKI) plus toripalimab (PD-1 inhibitor) and mFOLFIRINOX (chemotherapy) works as neoadjuvant therapy for patients with high-risk or borderline resectable pancreatic cancer. It will also learn about the safety of the combination regimen. The main questions it aims to answer are: Does the treatment regimen of surufatinib combined with immunotherapy and chemotherapy could provide further survival benefits for patients with high-risk resectable or borderline resectable pancreatic cancer as neoadjuvant therapy? Is the safety of this combination therapy tolerable? Participants will: Take surufatinib (200mg, qd, po, q2w), Toripalimab (3mg/kg, iv, d1, q2w), Oxaliplatin (68 mg/m², iv, d1, q2w), Irinotecan (135 mg/m², iv, d1, q2w), Calcium folinate (400 mg/m², iv, d1, q2w), 5-FU (2400 mg/m², iv). Treatment for up to 8 cycles. Visit the clinic once every 8 weeks (± 7 days) for checkups and tests. Keep a diary of their symptoms and record daily medication doses.

Timeline

Start
2026-03-31
Primary completion
2028-01-31
Completion
2029-01-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Irinotecan Small molecule 135 mg/m2 Intravenous
Subject Leucovorin Small molecule 400 mg/m2 Intravenous
Subject Oxaliplatin Small molecule 68 mg/m2 Intravenous
Subject Surufatinib Small molecule 200 mg Oral
Subject Toripalimab Monoclonal antibody 3 mg/kg Intravenous
Subject fluorouracil Small molecule 2400 mg/m2 Intravenous

Indications