A Real World Study of Treatment Regimens Containing Camrelizumab in Patients With Advanced Liver Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Assess Safety as defined by the NCI CTCAE v5.0
研究概览
简要总结
To observe and evaluate the safety and efficacy of camrelizumab in advanced liver cancer
详细描述
camrelizumab ， a humanized monoclonal antibody against PD-1, has been shown to block the binding of PD-1 to PD-L1, thereby inhibiting the immune escape of tumor cells. It has a high affinity for PD-1 (KD = 3.31 nmol/L), a high acceptor proportion (85% at 200 mg) of circulating T lymphocytes, and binds to epitopes different from Nivolumab and pembrolizumab，Phase 1 clinical trials have shown that camrelizumab is well tolerated and has antitumor activity in patients with advanced solid tumors.camrelizumab has been approved for indication for advanced hepatocellular carcinoma The main objective of this study was to observe and evaluate the safety and efficacy of treatment regiments containing Camrelizumab in advanced liver cancer。 The subjects included people over 18 years old， For men and women with advanced liver cancer confirmed by histopathology or cytology;
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years old or more;
- •For both men and women;
- •Patients with advanced liver cancer confirmed by histopathology or cytology; .Volunteer to join the study, sign the informed consent, good compliance, and cooperate with the follow-up.
排除标准
- •A known allergy to the study drug or any of its excipients; Or had a severe allergic reaction to other monoclonal antibodies;
- •Patients who are ready for or have previously received an organ or allogeneic bone marrow transplant;
- •Pregnant or lactating women;
- •According to the judgment of the researcher, the patients should not be included in this study
结局指标
主要结局
Assess Safety as defined by the NCI CTCAE v5.0
时间窗: From patients participate in the clinical study to 90 days after the end of treatment
Adverse events as graded by CTCAE v5.0
次要结局
- overall survival(5 years)