Clinical Trial

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

Not Yet Recruiting Phase 3
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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).
Trial Details
NCT Number NCT07445295
Lead Sponsor Chipscreen Biosciences, Ltd.
Conditions Metastatic Pancreatic Ductal Adenocarcinoma
Enrollment 558 participants
Start Date 2026-03-31
Primary Completion 2028-06-30 (estimated)
Study Completion 2028-11-30 (estimated)
Updated on ClinicalTrials.gov 2026-03-03