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

NCT07445295 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 558

Last updated 2026-03-03

No results posted yet for this study

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

Interventions

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

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

Chiauranib

50 mg, oral administration once daily

Sponsors & Collaborators

  • Chipscreen Biosciences, Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2026-03-31
Primary Completion
2028-06-30
Completion
2028-11-30

Countries

  • China

Study Locations

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Entities

Diseases

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 NCT07445295 on ClinicalTrials.gov