Camrelizumab in Patients With Unresectable Hepatocellular Carcinoma in China: a Real-world Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 1,000
- 主要终点
- The incidence of treatment-emergent adverse events (TEAE)
研究概览
简要总结
Primary liver cancer is the second most common cause of cancer death in China, and hepatocellular carcinoma (HCC) represents more than 80% of liver cancer cases. The majority of HCC cases present at an advanced stage, and are thus not amenable to surgery. Immunotherapies, including PD-1 and PD-L1 inhibitors, alone or combined with other regimens, have shown encouraging clinical activity in unresectable HCC. Camrelizumab, a humanised monoclonal antibody against PD-1, has been shown to block the binding of PD-1 to PD-L1 and consequently inhibit the immune escape of tumour cells， which has been approved for the second-line treatment of advanced HCC. This observational study aims to evaluate the safety and efficacy of camrelizumab in Chinese unresectable HCC in the real world.
详细描述
Primary liver cancer is the second most common cause of cancer death in China, and hepatocellular carcinoma (HCC) represents more than 80% of liver cancer cases. The majority of HCC cases present at an advanced stage, and are thus not amenable to surgery. Immunotherapies, including PD-1 and PD-L1 inhibitors, alone or combined with other regimens, have shown encouraging clinical activity in unresectable HCC. Camrelizumab, a humanised monoclonal antibody against PD-1, has been shown to block the binding of PD-1 to PD-L1 and consequently inhibit the immune escape of tumour cells，which has been approved for the second-line treatment of advanced HCC. This multi-center, open-label, observational study aims to evaluate the safety and efficacy of camrelizumab in Chinese unresectable HCC in the real world. This study also aims to evaluate the treatment of camrelizumab in subgroups, to provide information of treatment regimens and efficacy in clinical practice. The anticipated sample size is 1000, and the camrelizumab-based treatment will be determined by the investigator.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
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
- •Volunteer to participate in this study and sign an informed consent form;
- •Age ≥ 18 years;
- •Hepatocellular carcinoma confirmed/clinically confirmed by histopathology, cytology or imaging
排除标准
- •Documented pregnant or breastfeeding women;
- •Patients who are participating in any interventional trials beyond clinical practice.
结局指标
主要结局
The incidence of treatment-emergent adverse events (TEAE)
时间窗: Up to ~2 years
The incidence of treatment-emergent adverse events (TEAE)
次要结局
- Overall survival(Up to ~2 years)
- Progression-free survival(Up to ~2 years)
- Time to progression(Up to ~2 years)
研究者
Jian Zhou
Chief physician
Shanghai Zhongshan Hospital