Chemotherapy Combined With Adebrelimab and Mecapegfilgrastim in Neoadjuvant Treatment of Potentially Resectable BTC (Modified)

Nanjing Medical University

Status and phase

Not yet enrolling

Phase 2

Conditions

Biliary Tract Neoplasms

Treatments

Drug: Total Neoadjuvant Treatment

Study type

Interventional

Funder types

Other

Identifiers

NCT06037655

MA-BTC-II-002

Details and patient eligibility

About

The purpose of this study is to assess the safety and efficacy of Gemcitabine/cisplatin combined with Adebrelimab and Mecapegfilgrastim in neoadjuvant treatment of potentially resectable Biliary Tract Neoplasms.

Full description

After being informed about the study and potential risks, patients giving written informed consent will undergo a 1-week screening period to determine eligibility for study entry. At week 0, patients who meet the eligibility requirements will be receive Gemcitabine/cisplatin combined with Adebrelimab and Mecapegfilgrastim three weeks a cycle, surgery was performed after 4 cycles.

Enrollment

30 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Male or female
Age ≥ 18 years，≤ 75 years
Patients with untreated resectable locally advanced biliary tract cancer (BTC) who are difficult to directly resecte surgically
Ability to provide written informed consent prior to participation in any study-related procedure
Eastern Cooperative Oncology Group (ECOG) performance status 0-1
At least one, not previously irradiated, measurable lesion according to RECIST (version 1.1).
Adequate organ function

Exclusion criteria

Diagnosis of mixed ampullary, hepatocellular, and cholangiocarcinoma
Known history of a serious allergy to any monoclonal antibody
Any active malignancy prior to the start of treatment
Active or history of autoimmune disease
Other acute or chronic conditions, psychiatric disorders, or laboratory abnormalities that may increase the risk of study participation
Pregnant or lactating women