Gemcitabine/Cisplatin Combined With Adebrelimab and Mecapegfilgrastim in Neoadjuvant Treatment of Potentially Resectable Biliary Tract Carcinoma, A Single-arm Study
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 30
- 主要终点
- Objective response rate (ORR)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Experimental
NeoAdjuvant Therapy with Adebrelimab plus Mecapegfilgrastim and Gemcitabine/cisplatin followed by the operation
干预措施: Total Neoadjuvant Treatment (Drug)
结局指标
主要结局
Objective response rate (ORR)
时间窗: 18 weeks
ORR is defined as patients achieving clinical complete response (CR) or partial response (PR) according to RECIST v1.1
次要结局
- overall survival (OS)(2 years)