Overview

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

Status:
NOT_YET_RECRUITING

Trial end date:
2028-09-30

Target enrollment:

Participant gender:

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).

Phase:

PHASE2

Details

Lead Sponsor:

Second Affiliated Hospital, School of Medicine, Zhejiang University

Collaborator:

Innovent Biologics (Suzhou) Co. Ltd.

Treatments:

Albumin-Bound Paclitaxel
Bevacizumab
Gemcitabine