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).
Signed written informed consent prior to any trial-related procedures.
Male or female aged **≥18 years and ≤75 years**.
Histologically or cytologically confirmed, surgically unresectable locally advanced or metastatic cholangiocarcinoma.
No prior systemic therapy; subjects who completed postoperative adjuvant therapy **>6 months ago** are eligible.
Other malignancies within 5 years prior to first dose (excluding radically cured basal cell carcinoma, squamous cell carcinoma of skin, or carcinoma in situ).
Current participation in interventional clinical trials or receipt of other investigational drugs/devices within 4 weeks before first dose.
Anti-PD-1/PD-L1/PD-L2 agents;
Drugs targeting stimulatory/co-inhibitory T-cell receptors (e.g., CTLA-4, OX-40, CD137).
Second Affiliated Hospital, School of Medicine, Zhejiang University
Lead sponsor
Innovent Biologics (Suzhou) Co. Ltd.
Collaborator