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

NCT07469956 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-03-13

No results posted yet for this study

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.

Conditions

  • Pancreatic Cancer Resectable

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.

Sponsors & Collaborators

  • Sun Yat-sen University

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07469956 on ClinicalTrials.gov