NCT05908747

Efficacy and Safety of Surufatinib Combined With Gemcitabine and Albumin-bound Paclitaxel in the Peri-operative Treatment of Pancreatic Cancer

Efficacy and Safety of Surufatinib Combined With Gemcitabine and Albumin-bound Paclitaxel in the Peri-operative Treatment of Locally Advanced or Borderline Resectable Pancreatic Cancer: An Exploratory Study

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 29 (estimated)
• Sponsor: Tianjin Medical University Cancer Institute and Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study is designed to explore the efficacy and safety of surufatinib combined with gemcitabine and nab-paclitaxel as peri-operative treatment in locally advanced or borderline resectable pancreatic cancer.

Detailed description

This is a phase II, multi-centered, open-label study, aims to explore the efficacy and safety of surufatinib (250mg, qd po) combined with gemcitabine (1000mg/m2, I.V, d1/8/15, Q4W) and nab-paclitaxel (125mg/m2, I.V, d1/8/15, Q4W) as peri-operative treatment in locally advanced or borderline resectable pancreatic cancer. Potential therapeutic biomarkers will also be explored.

Conditions

• Pancreatic Cancer

Interventions

Type	Name	Description
DRUG	surufatinib + gemcitabine + nab-paclitaxel	surufatinib: 250mg, QD po; nab-paclitaxel: 125mg/m2, I.V., D1/8/15, Q4W; gemcitabine: 1000/m2, ivgtt for more than 30min, D1/8/15, Q4W

Timeline

• Start date: 2023-05-31
• Primary completion: 2025-05-16
• Completion: 2026-05-01
• First posted: 2023-06-18
• Last updated: 2026-02-10

Locations

1 site across 1 country: China