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NOT YET RECRUITING
NCT07833241
PHASE2

Surufatinib in Combination With Iparomlimab and Tuvonralimab Injection and AG Chemotherapy for Neoadjuvant Therapy of HRPC or BRPC

Sponsor: Shanghai Zhongshan Hospital

View on ClinicalTrials.gov

Summary

This is a prospective, single-center, single-arm phase 2 study evaluating the efficacy and safety of neoadjuvant surufatinib plus iparomlimab and tuvonralimab injection and nab-paclitaxel/gemcitabine chemotherapy in patients with high-risk resectable or borderline resectable pancreatic cancer. Approximately 56 participants will be enrolled, including about 19 patients with high-risk resectable disease and 37 patients with borderline resectable disease. Participants will receive up to four 21-day cycles of neoadjuvant treatment. Participants considered eligible for surgery will undergo surgical resection approximately 4 weeks after neoadjuvant treatment. After surgery, adjuvant chemotherapy with either gemcitabine plus capecitabine or modified FOLFIRINOX will be selected by the investigators after multidisciplinary team review. The primary outcome is the 12-month event-free survival rate.

Official title: Neoadjuvant Surufatinib in Combination With Iparomlimab and Tuvonralimab Injection and AG Chemotherapy for High-risk Resectable or Borderline Resectable Pancreatic Cancer: a Single-arm, Single-center, Exploratory Clinical Study

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

56

Start Date

2026-09-01

Completion Date

2029-09-01

Last Updated

2026-09-22

Healthy Volunteers

No

Interventions

DRUG

Surufatinib Plus Iparomlimab and Tuvonralimab and AG Chemotherapy

Surufatinib 200 mg orally once daily; iparomlimab and tuvonralimab injection 5 mg/kg intravenously every 21 days; nab-paclitaxel 125 mg/m² and gemcitabine 1000 mg/m² intravenously on Days 1 and 8 of each 21-day cycle, for up to four cycles.

DRUG

Gemcitabine plus Capecitabine

After surgery, eligible participants may receive gemcitabine 1000 mg/m² intravenously on Days 1 and 8 plus capecitabine 1650-2000 mg/m²/day orally on Days 1-14 of each 21-day cycle.

DRUG

Modified FOLFIRINOX

After surgery, eligible participants may receive oxaliplatin 85 mg/m², irinotecan 150 mg/m², leucovorin 400 mg/m², and fluorouracil 2400 mg/m² every 14 days.

Locations (1)

Shanghai Zhongshan Hospital

Shanghai, China