Clinical Trial

Exploration of Sintilimab + Bevacizumab + AG Chemotherapy as First-Line Treatment for Unresectable Advanced/Metastatic Cholangiocarcinoma

Not Yet Recruiting Phase 2

Summary

Evaluation of Efficacy and Safety of Sintilimab Plus Bevacizumab and AG Regimen as First-Line Therapy in Patients with Surgically Ineligible Locally Advanced or Metastatic Cholangiocarcinoma Objectives: Primary Objective: To assess the objective response rate (ORR) as per RECIST v1.1. Secondary Objectives: 1. To evaluate the disease control rate (DCR) per RECIST v1.1. 2. To determine the duration of response (DOR) per RECIST v1.1. 3. To measure progression-free survival (PFS) per RECIST v1.1. 4. To characterize the safety profile. 5. To determine overall survival (OS) . Exploratory Objectives: To investigate potential predictive biomarkers (e.g., PD-L1 expression, tumor mutational burden \[TMB\]) and their correlation with treatment efficacy (non-mandatory).

Protocol Amendment History 1 change

notable Sponsor changed: Second Affiliated Hospital, School of Medicine, Zhejiang University -> Second Affiliated Hospital, Zhejiang University, School of Medicine 2026-08-09

Trial Details

NCT Number	NCT07328802
Lead Sponsor	Second Affiliated Hospital, School of Medicine, Zhejiang University Collaborators: Innovent Biologics (Suzhou) Co. Ltd.
Conditions	ORR,OS,PFS
Enrollment	25 participants
Start Date	2026-01-01
Primary Completion	2028-09-30 (estimated)
Study Completion	2028-09-30 (estimated)
Updated on ClinicalTrials.gov	2026-01-09