A Real-world Study of Immunotherapy-based Combination Therapies in Chinese Patients With Hepatocellular Carcinoma
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 11,000
- 试验地点
- 1
- 主要终点
- Adverse events
研究概览
简要总结
This study is an observational real-world research conducted on Chinese hepatocellular carcinoma (HCC) patients. Its primary objective is to evaluate the safety and efficacy of immunotherapy-based combination therapies in Chinese HCC patients within the practical context of real-world conditions.
详细描述
Hepatocellular carcinoma exhibits a significantly elevated incidence and mortality rate in China. Despite the Chinese population representing a mere 18.4% of the global population, the annual incidence of new liver cancer cases reaches a staggering 466,000 (55.4% of the global total), with 422,000 deaths (53.9% of the global total). Immunotherapy, particularly the implementation of immunotherapy-based combination treatment regimens, holds substantial therapeutic value in the management of hepatocellular carcinoma (HCC), leading to notable breakthroughs and advancements in the comprehensive treatment of liver cancer. The aim of this study is to evaluate the safety and efficacy of immunotherapy-based combination treatment regimens in Chinese hepatocellular carcinoma (HCC) patients under real-world clinical conditions. By collecting and analyzing data on the etiology, clinical characteristics, treatment modalities, and treatment outcomes of HCC patients receiving immunotherapy-based combination treatments in the clinical healthcare setting, the study seeks to provide valuable information regarding treatment patterns and effectiveness for hepatocellular carcinoma patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Other
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
- •Aged after 18 years (18 is included).
- •Hepatocellular carcinoma diagnosed by pathology or imaging.
- •Patients assessed by researchers as potentially benefiting from receiving immunotherapy-based combination regimens.
- •For participants who have previously received treatment according to this protocol, a comprehensive pre-treatment assessment is required, including demographic information, tumor history, medical history, and baseline imaging examinations.
- •Patients voluntarily enroll in this study.
排除标准
- •Pregnant or lactating women.
- •Other conditions regimented at investigators' discretion.
结局指标
主要结局
Adverse events
时间窗: 24 months
All adverse events during the course of the study treatment.
次要结局
- Progression free survival(24 months)
- Overall survival(24 months)
- Disease control rate(24 months)
- Objective response rate(24 months)
- Duration of response(24 months)