NCT07445295

Chiauranib Plus PD-1 Inhibitor, Albumin-paclitaxel and Gemcitabine in Patients With Metastatic Pancreatic Ductal Adenocarcinoma

A Phase III Study of Chiauranib Plus PD-1 Inhibitor, Albumin-paclitaxel and Gemcitabine as First-line Therapy in Patients With Metastatic Pancreatic Ductal Adenocarcinoma

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 558 (estimated)
• Sponsor: Chipscreen Biosciences, Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a phase III, multi-center study to evaluate the efficacy and safety of chiauranib plus plus toripalimab, albumin-paclitaxel and gemcitabine as first-line therapy in patients with metastatic pancreatic ductal adenocarcinoma. The study includes two period: Run-in period and Randomized controlled period. The Run-in period is a single-arm, open-label study enrolling approximately 20 participants, who received the combination therapy of chiauranib plus toripalimab, albumin-paclitaxel and gemcitabine. The Randomized controlled period is a randomized, double-blind, parallel-controlled study enrolling approximately 538 participants, who are 1:1 randomly assigned to the experimental arm(chiauranib plus Toripalimab, albumin-paclitaxel and gemcitabine) or the control arm (Chiauranib placebo plus toripalimab placebo, albumin-paclitaxel and gemcitabine).

Conditions

• Metastatic Pancreatic Ductal Adenocarcinoma

Interventions

Type	Name	Description
DRUG	Chiauranib	50 mg, oral administration once daily
DRUG	Toripalimab Injection	3mg/kg, maximum dose 240mg, administered intravenously on Days 1 and 15 of each 28-day cycle
DRUG	Albumin-paclitaxel Injection	125 mg/m\^2, administered intravenously on Days 1, 8 and 15 of each 28-day cycle
DRUG	Gemcitabine Injection	1000 mg/m\^2, administered intravenously on Days 1, 8 and 15 of each 28-day cycle
DRUG	Chiauranib placebo	50 mg, oral administration once daily
DRUG	Toripalimab Injection placebo	3mg/kg, maximum dose 240mg, administered intravenously on Days 1 and 15 of each 28-day cycle

Timeline

• Start date: 2026-03-31
• Primary completion: 2028-06-30
• Completion: 2028-11-30
• First posted: 2026-03-03
• Last updated: 2026-03-03

Locations

1 site across 1 country: China