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NOT YET RECRUITING
NCT07469956
PHASE2

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

Sponsor: Sun Yat-sen University

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

30

Start Date

2026-03-31

Completion Date

2029-01-31

Last Updated

2026-03-13

Healthy Volunteers

No

Interventions

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.

Locations (1)

Sun Yat-sen University Cancer Center

Guangzhou, China