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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Gemcitabine/Cisplatin Combined With Adebrelimab and Mecapegfilgrastim in Neoadjuvant Treatment of Potentially Resectable Biliary Tract Carcinoma, A Single-arm Study

Conditions
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Biliary Tract Neoplasms

Intervention / Treatment
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* Drug: Total Neoadjuvant Treatment


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental<br>NeoAdjuvant Therapy with Adebrelimab plus Mecapegfilgrastim and Gemcitabine/cisplatin followed by the operation | Drug: Total Neoadjuvant Treatment<br>* Adebrelimab (1200 mg) every three weeks intravenously; Mecapegfilgrastim (6 mg) every three weeks intravenously; Gemcitabine (1000 mg/m2) every three weeks on days 1 and 8 intravenously; Cisplatin (25 mg/m2) every three weeks on days 1 and 8 intravenously<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective response rate (ORR) | ORR is defined as patients achieving clinical complete response (CR) or partial response (PR) according to RECIST v1.1 | 18 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival (OS) | Overall survival | 2 years |