To clarify the effectiveness and safety of compound kushen injection in the treatment of advanced colorectal cancer.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
320
FOLFOX/FOLFIRI/CAPEOX± Cetuximab/bevacizumab+compound kushen injection Compound Kushen injection: intravenous infusion, 20ml at a time, diluted with 200ml sodium chloride injection, once a day, each cycle of chemotherapy should reach the cumulative dose of 200ml.
FOLFOX/FOLFIRI/CAPEOX± Cetuximab/bevacizumab
Guang 'anmen Hospital, China Academy of Chinese Medical Sciences
Beijing, China
RECRUITINGPFS
Progression Free Survival
Time frame: The time from randomization to tumor progression or death in patients, whichever came first, assessed up to 24 months
OS
Overall survival
Time frame: The time from randomization to death from any cause after enrollment, whichever occurs first, assessed up to 24 months
1-year survival rate
The probability of patients surviving more than 1 year after treatment
Time frame: 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 the total patients who does not with tumor progression or death within 1 year from enrollment.
Time frame: The proportion of patients with tumor progression or death from enrollment.
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