Chemotherapy Combined With Adebrelimab and Mecapegfilgrastim in Neoadjuvant Treatment of Potentially Resectable BTC
Phase 2
Not yet recruiting
- Conditions
- Biliary Tract Neoplasms
- Interventions
- Drug: Total Neoadjuvant Treatment
- Registration Number
- NCT06037655
- 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 30
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Experimental Total Neoadjuvant Treatment NeoAdjuvant Therapy with Adebrelimab plus Mecapegfilgrastim and Gemcitabine/cisplatin followed by the operation
- Primary Outcome Measures
Name Time Method Objective response rate (ORR) 18 weeks ORR is defined as patients achieving clinical complete response (CR) or partial response (PR) according to RECIST v1.1
- Secondary Outcome Measures
Name Time Method overall survival (OS) 2 years Overall survival