Actively Recruiting

Phase 2
Age: 18Years - 80Years
All Genders
NCT07135544

A Single-arm, Multicenter, Exploratory Study of Adebrelimab Combined With Apatinib and Systemic Chemotherapy for Initially Unresectable Biliary Tract Cancer

Led by Yongjun Chen · Updated on 2025-08-22

37

Participants Needed

1

Research Sites

176 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This is an exploratory and prospective study, with the research subjects being patients with initially untreated and unresectable biliary tract tumors. The efficacy and safety of the treatment regimen consisting of Adebrelimab monoclonal antibody combined with targeted therapy and systemic chemotherapy were investigated.

CONDITIONS

Official Title

A Single-arm, Multicenter, Exploratory Study of Adebrelimab Combined With Apatinib and Systemic Chemotherapy for Initially Unresectable Biliary Tract Cancer

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Pathological or histological diagnosis of malignant biliary tract tumor
  • Classified as TxNx or TxNxM1 stage and judged incurable or unsuitable for surgery
  • Age between 18 and 80 years
  • Expected survival longer than 3 months
  • Both genders are eligible
  • ECOG performance status score of 0 or 1
  • No severe complications such as hypertension, coronary heart disease, or severe allergy history
  • Non-pregnant and non-lactating
  • Adequate organ and blood function, including neutrophil count, platelet count, hemoglobin, bilirubin, liver enzymes, albumin, and creatinine within defined limits
  • Ability to understand and sign informed consent
  • Newly diagnosed and untreated patients, or those with recurrence 2 years after radical biliary cancer surgery
  • Use of medically approved contraception for patients of potential fertility, with negative pregnancy test within 72 hours before enrollment
Not Eligible

You will not qualify if you...

  • Prior treatment with immune checkpoint inhibitors or other T-cell receptor therapies
  • Use of investigational drugs within 4 weeks before enrollment
  • Active or history of autoimmune diseases requiring treatment
  • Congenital or acquired immune deficiencies, active hepatitis B or C infection
  • Serious infections within 4 weeks before first treatment or unexplained fever above 38.5°C
  • History of organ or hematopoietic stem cell transplantation
  • Uncontrolled mental disorders
  • Severe or uncontrolled diseases affecting study participation, including unstable heart conditions, poorly controlled diabetes, infections after biliary drainage
  • Other cancers within past 5 years except non-melanoma skin cancer or carcinoma in situ
  • Allergy or hypersensitivity to study drugs or monoclonal antibodies
  • Unable or unwilling to provide informed consent

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, China, 430030

Actively Recruiting

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Research Team

Y

Yongjun Chen Yongjun Chen

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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