Chemotherapy Combined with Immunotherapy and Targeted Therapy in Advanced Intrahepatic Cholangiocarcinoma
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Overall survival (OS)
研究概览
简要总结
This study aims to validate the efficacy and safety of GP/GEMOX combined with PD-1/L1 inhibitors and TKI agents in patients with advanced cholangiocarcinoma through a multicenter, retrospective study to guide clinical practice.
详细描述
This study plans to enroll patients diagnosed with advanced cholangiocarcinoma. After confirming patients treated with GP/GEMOX or GP/GEMOX combined with PD-1/L1 and TKI agents as initial therapy, the investigators will collect relevant clinical data, including basic clinical information, laboratory data, imaging data, pathological data, and surgical data through an electronic medical record system.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically or radiologically confirmed intrahepatic cholangiocarcinoma
- •Initially treated with GP/GEMOX or GP/GEMOX combined with PD-1/L1 and TKI inhibitors
排除标准
- •Direct surgery after hospitalization
- •Initial treatment combined with local therapies (radiotherapy, radiofrequency, particle implantation, TACE, etc.)
- •Initial treatment involving other comprehensive therapeutic regimens
研究组 & 干预措施
Control group
Patients initially received GP/GEMOX regimen.
干预措施: Gemcitabine combined with cisplatin or oxaliplatin (Drug)
Experimental group
Patients initially received GP/GEMOX combined with PD-1/L1 and TKI inhibitors regimen.
干预措施: Gemcitabine combined with cisplatin or oxaliplatin, PD-1/L1 and TKI inhibitors (Drug)
结局指标
主要结局
Overall survival (OS)
时间窗: 1 year
Overall survival (OS) is defined as the time from cancer diagnosis to death from any cause.
次要结局
- Progression-free survival (PFS)(1 year)