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NCT07328802

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

Not yet recruiting Phase 2 Last updated 9 January 2026
What this trial tests

Phase 2 trial testing Sintilimab combined with bevacizumab and albumin-bound paclitaxel plus gemcitabine in ORR,OS,PFS in 25 participants. Not yet recruiting.

Timeline
1 January 2026
Primary endpoint
30 September 2028
30 September 2028

Quick facts

Lead sponsorSecond Affiliated Hospital, School of Medicine, Zhejiang University
PhasePhase 2
StatusNot yet recruiting
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment25
Start date1 January 2026
Primary completion30 September 2028
Estimated completion30 September 2028
Sites1 location across China

Drugs / interventions tested

Conditions studied

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Who can join

Adults 18 to 75, any sex, with ORR,OS,PFS. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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).

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other recruiting trials for ORR,OS,PFS

Currently open trials in the same condition.

Other Second Affiliated Hospital, School of Medicine, Zhejiang University trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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