RecruitingPhase 2NCT07668453

An Open-label, Single-arm, Multicenter Exploratory Study of Adebrelimab Combined With Gemcitabine and Albumin-bound Paclitaxel as First-line Treatment for Biliary Tract Malignancies


Sponsor

The First Affiliated Hospital with Nanjing Medical University

Enrollment

30 participants

Start Date

Oct 20, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of this clinical trial is to evaluate the safety and effectiveness of a new combination therapy for patients with biliary tract cancer that cannot be removed by surgery. Participants will receive an immunotherapy drug called adebrelimab combined with two chemotherapy drugs (gemcitabine and albumin-bound paclitaxel) as their first-line treatment. This is an open-label, single-arm study, meaning all enrolled patients will receive this same combination treatment. The main goal of the study is to determine the Objective Response Rate (ORR), which measures the proportion of patients whose tumors shrink in response to the treatment. Researchers will also evaluate how long patients live without the disease getting worse (Progression-Free Survival), overall survival, quality of life, and any side effects experienced. The study plans to enroll 30 participants.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a biological treatment called Adebrelimab, a drug called Albumin-Bound Paclitaxel /nab-Paclitaxel, and others for people with biliary tract neoplasms. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years to 75 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALAdebrelimab

1200 mg, intravenous (IV) infusion, administered on Day 1 of each 21-day cycle.

DRUGgemcitabine

800 mg/m\^2, intravenous (IV) infusion, administered on Days 1 and 8 of each 21-day cycle.

DRUGAlbumin-Bound Paclitaxel /nab-Paclitaxel

100 mg/m\^2, intravenous (IV) infusion, administered on Days 1 and 8 of each 21-day cycle.


Locations(1)

Jiangsu Provincial People's Hospital

Nanjing, Jiangsu, China

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NCT07668453


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