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The Safety and Efficacy of Benmelstobart Injection in Patients With Advanced Biliary Tract Malignant Tumors

NCT07109167 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-08-07

No results posted yet for this study

Summary

Evaluate the progression-free survival (PFS) of benmelstobart combined with gemcitabine and cisplatin in first-line patients with advanced cholangiocarcinoma, and the progression-free survival (PFS) of benmelstobart combined with anlotinib in second-line patients with advanced cholangiocarcinoma.

Conditions

  • Biliary Tract Neoplasms

Interventions

DRUG

Benmelstobart combined with gemcitabine and cisplatin

Benmelstobart 1200mg, intravenous infusion on Day 1;Gemcitabine 1000mg/m², intravenous infusion over 30 minutes on Day 1 and Day 8;Cisplatin 25mg/m², intravenous infusion on Day 1 and Day 8. Maintenance dose of study medication: Benmelstobart 1200mg, intravenous infusion on Day 1;Gemcitabine 1000mg/m², intravenous infusion over 30 minutes on Day 1 and Day 8

Sponsors & Collaborators

  • The Second Affiliated Hospital of Shandong First Medical University

    lead OTHER

Principal Investigators

  • yan hai Liu · The Second Affiliated Hospital of Shandong First Medical University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-01
Primary Completion
2026-08-01
Completion
2027-08-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07109167 on ClinicalTrials.gov