Exploration of Sintilimab + Bevacizumab + AG Chemotherapy as First-Line Treatment for Unresectable Advanced/Metastatic Cholangiocarcinoma
brief 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).
detailed description
This study is a single-arm, Phase II clinical trial evaluating the efficacy and safety of Sintilimab plus Bevacizumab and the AG regimen as first-line therapy in patients with surgically ineligible locally advanced or metastatic cholangiocarcinoma.
After providing informed consent, patients receive:
Sintilimab: 200 mg IV Q3W Bevacizumab: 15 mg/kg IV Q3W AG Chemotherapy: Nab-paclitaxel + Gemcitabine for 8 cycles.
Post-chemotherapy, patients continue Sintilimab + Bevacizumab maintenance until:
Disease progression Death Intolerable toxicity Withdrawal of consent Initiation of new antitumor therapy Other protocol-specified reasons (Maximum treatment duration: 24 months)
official title
Clinical Study Protocol for a Single-Center, Prospective, Single-Arm Trial Assessing Icaritin Soft Capsules as Postoperative Adjuvant Therapy in Hepatocellular Carcinoma Patients With High-Risk Factors for Recurrence