Exploration of Sintilimab + Bevacizumab + AG Chemotherapy as First-Line Treatment for Unresectabl… (NCT07328802) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Exploration of Sintilimab + Bevacizumab + AG Chemotherapy as First-Line Treatment for Unresectable Advanced/Metastatic Cholangiocarcinoma
China25 participantsStarted 2026-01-01
Plain-language 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).
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. 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.
✓. Life expectancy \>3 months.
✓. At least one measurable lesion per RECIST 1.1 criteria.
✓. ECOG PS score 0 or 1.
✓. Adequate organ function (all laboratory criteria below must be met):
Exclusion criteria
✕. Other malignancies within 5 years prior to first dose (excluding radically cured basal cell carcinoma, squamous cell carcinoma of skin, or carcinoma in situ).
✕
What they're measuring
1
Objective Response Rate (ORR)
Timeframe: From baseline (within 28 days prior to enrollment) through disease progression or study completion, up to approximately 2 years.
Trial details
NCT IDNCT07328802
SponsorSecond Affiliated Hospital, School of Medicine, Zhejiang University