Gemcitabine/Cisplatin Combined With Adebrelimab and Mecapegfilgrastim in Neoadjuvant Treatment of Potentially Resectable Biliary Tract Carcinoma, A Single-arm Study
Trial Snapshot
- Phase
- Phase 2
- Status
- Not yet recruiting
- Enrollment
- 30
- Primary Endpoint
- Objective response rate (ORR)
Study Overview
Brief Summary
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
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Experimental
NeoAdjuvant Therapy with Adebrelimab plus Mecapegfilgrastim and Gemcitabine/cisplatin followed by the operation
Intervention: Total Neoadjuvant Treatment (Drug)
Outcomes
Primary Outcomes
Objective response rate (ORR)
Time Frame: 18 weeks
ORR is defined as patients achieving clinical complete response (CR) or partial response (PR) according to RECIST v1.1
Secondary Outcomes
- overall survival (OS)(2 years)