Survival Benefit of Compound Kushen Injection in Treatment of Advanced Colorectal Cancer Based on Real World Registration Platform
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 320
- 试验地点
- 1
- 主要终点
- PFS
研究概览
简要总结
To clarify the effectiveness and safety of compound kushen injection in the treatment of advanced colorectal cancer.
详细描述
This study include a multi-center, randomized, parallel controlled clinical trial. The randomized clinical trial will enroll approximately 320 patients. Participants will be randomly divided into experimental (n=160) and control groups (n=160). Patients in the experimental group was treated with first-line scheme + compound kushen injection. Patients in the control group will receive first-line scheme. The primary endpoint is PFS. The research protocol was approved by the relevant ethics committees, and the study was conducted according to the Declaration of Helsinki and Good Clinical Practice guidelines. Patients gave written informed consent to participate in the trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •① Patients with advanced CRC confirmed by pathology or cytology and receiving first-line therapy;② Aged ≥ 18 years old, male or female;③ ECOG score 0-2 points;④ Expected survival ≥ 3 months;⑤ According to RECIST1.1 criteria, at least one detectable lesion;⑥ Voluntarily join the study, sign informed consent, compliance with good cooperation with follow-up.
排除标准
- •Combined with other malignant primary tumors;
- •Immunohistochemistry/polymerase chain reaction/second-generation sequencing results suggest MSI-H/dMMR patients;
- •Patients with recurrence and metastasis within 6 months after radical tumor surgery;
- •Patients who have previously or are undergoing cancer immunotherapy ; Patients undergoing radiation therapy;
- •Pregnant or lactating women; women of childbearing age and their spouses can not take effective contraceptive measures during and within 6 months after the end of clinical study; ⑥ Psychiatric patients; ⑦ Patients with severe, uncontrolled organic disease or infection, such as decompensated heart, lung, kidney failure caused by intolerance to chemotherapy; ⑧ Patients who have received clinical trials of small molecule drugs within 28 days or received clinical trials of large molecule drugs within 3 months; ⑨ Patients who are known to be allergic to or intolerant of study drugs.
研究组 & 干预措施
first-line scheme + compound kushen injection
Compound Kushen injection+first-line regimen (FOLFOX/FOLFIRI/CAPEOX± Cetuximab/bevacizumab)+
干预措施: first-line scheme+compound kushen injection (Drug)
first-line scheme
first-line regimen (FOLFOX/FOLFIRI/CAPEOX± Cetuximab/bevacizumab)
干预措施: palliative care group first-line scheme (Drug)
结局指标
主要结局
PFS
时间窗: The time from randomization to tumor progression or death in patients, whichever came first, assessed up to 24 months
Progression Free Survival
次要结局
- OS(The time from randomization to death from any cause after enrollment, whichever occurs first, assessed up to 24 months)
- 1-year survival rate(The proportion of patients with survival period of more than 1 year accounted for the total patients from the beginning of enrollment treatment)
- 1-year PFS rate(The proportion of patients with tumor progression or death from enrollment.)
研究者
Jie Li
Vice President
Guang'anmen Hospital of China Academy of Chinese Medical Sciences