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).
Single group
Sintilimab combined with bevacizumab and albumin-bound paclitaxel plus gemcitabine
DrugPatients receive sintilimab (200mg IV Q3W) combined with bevacizumab (15mg/kg IV Q3W) and the AG regimen (albumin-bound paclitaxel + gemcitabine). AG chemotherapy is administered for a total of 8 cycles. After completion of chemotherapy, patients continue sintilimab plus bevacizumab maintenance therapy until disease progression, death, intolerable toxicity, withdrawal of informed consent, initiation of new antitumor therapy, or other protocol-specified reasons for treatment discontinuation, with a maximum treatment duration of 24 months.
Objective Response Rate (ORR)
Tumor assessments are based on RECIST 1.1. Imaging modalities for this evaluation require: Mandatory scans (each cycle): Contrast-enhanced CT or MRI of the chest and abdomen Baseline assessments (within 28 days ): Contrast-enhanced CT/MRI of the pelvis Brain MRI Whole-body bone scan Additional baseline imaging if clinically indicated: Contrast-enhanced neck CT (if cervical lymphadenopathy present) PET/CT protocol: Acceptable for baseline screening only Any abnormal findings must undergo confirmatory anatomical imaging (CT/MRI) for target lesion designation
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Second Affiliated Hospital, School of Medicine, Zhejiang University
Lead sponsor
Innovent Biologics (Suzhou) Co. Ltd.
Collaborator
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