NCT07469956

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

Neoadjuvant Therapy With Surufatinib Combined With mFOLFIRINOX and Toripalimab for High-risk or Borderline Resectable Pancreatic Cancer: A Phase II, Single-arm, Single-center Study

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This study is a single-center, single-arm, phase II study. Preoperative neoadjuvant treatment plan: * Surufatinib: 200 mg orally once daily, continuous dosing, with a 14-day treatment cycle; * Toripalimab: 3 mg/kg per dose, intravenous infusion over 1 hour on day 1, every 14 days per treatment cycle; * Oxaliplatin: 68 mg/m² intravenous infusion over 2 hours on day 1; * Irinotecan: 135 mg/m² intravenous infusion over 30-90+ minutes on day 1; * Calcium folinate: 400 mg/m² intravenous infusion over 2 hours on day 1; * 5-FU: 2400 mg/m² continuous intravenous infusion over 46 hours; repeated every 14 days per treatment cycle. Neoadjuvant treatment will be administered for up to 8 cycles. During treatment, tumor assessments using imaging will be conducted every 8 weeks (±7 days). For patients achieving stable disease, partial response, or complete response, it will be evaluated whether surgery is feasible. Surgery should occur at least 2 weeks after the last neoadjuvant treatment. Postoperative adjuvant treatment plan: * Adjuvant treatment will begin within 4-8 weeks after surgery, with the specific regimen determined by the investigator. * During postoperative adjuvant treatment, tumor assessments using imaging will be conducted every 8 weeks (±7 days) until disease progression (RECIST 1.1) or death (during patient treatment), or until intolerable toxicity occurs. Subsequent treatment after disease progression and survival status will also be recorded.

Conditions

• Pancreatic Cancer Resectable

Interventions

Type	Name	Description
DRUG	Surufatinib	Surufatinib: 200 mg orally once daily, continuous dosing, with each 14 days as one treatment cycle
DRUG	Toripalimab	Toripalimab: 3 mg/kg per dose, intravenous infusion over 1 hour, on day 1, with each 14 days as one treatment cycle
DRUG	mFOLFIRINOX	Oxaliplatin: 68 mg/m² intravenous infusion over 2 hours, on day 1; Irinotecan: 135 mg/m² intravenous infusion over more than 30-90 minutes, on day 1; Calcium folinate: 400 mg/m² intravenous infusion over 2 hours, on day 1; 5-FU: 2400 mg/m² continuous intravenous infusion over 46 hours; With each 14 days as one treatment cycle; Neoadjuvant treatment for up to 8 cycles.

Timeline

• Start date: 2026-03-31
• Primary completion: 2028-01-31
• Completion: 2029-01-31
• First posted: 2026-03-13
• Last updated: 2026-03-13

Locations

1 site across 1 country: China