What this Trial Is About

Researchers are evaluating the effectiveness and safety of compound kushen injection in treating advanced colorectal cancer. This multi-center, randomized, parallel controlled clinical trial will include about 320 patients with advanced colorectal carcinoma confirmed by pathology or cytology. Participants will be randomly assigned to either an experimental group or a control group, each with 160 patients. The trial aims to measure progression-free survival (PFS), defined as the time from randomization to tumor progression or death, assessed up to 24 months. The study follows ethical guidelines and requires informed consent from participants. Patients in the experimental group will receive standard first-line chemotherapy regimens such as FOLFOX, FOLFIRI, or CAPEOX, with or without Cetuximab or Bevacizumab, combined with compound kushen injection. The compound kushen injection is administered as an intravenous infusion of 20ml diluted in 200ml sodium chloride once daily, with a cumulative dose of 200ml per chemotherapy cycle. The control group will receive the same first-line chemotherapy regimens without the compound kushen injection. The trial is conducted under phase 4 standards and includes standard supportive care. Participants will undergo regular assessments including tumor evaluations according to RECIST 1.1 criteria to monitor disease progression. Researchers will gather data on survival, tumor response, and safety outcomes throughout the study period. The study requires patients to have a minimum expected survival of 3 months and an ECOG score of 0 to 2. Follow-up and compliance with study procedures are monitored to ensure reliable data collection and participant safety throughout the trial duration.

Survival Benefit of Compound Kushen Injection in the Treatment of Advanced Colorectal Cancer