NCT05894694

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

Survival Benefit of Compound Kushen Injection in Treatment of Advanced Colorectal Cancer Based on Real World Registration Platform

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 320 (estimated)
• Sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To clarify the effectiveness and safety of compound kushen injection in the treatment of advanced colorectal cancer.

Detailed description

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.

Conditions

• Advanced Colorectal Carcinoma

Interventions

Type	Name	Description
DRUG	first-line scheme+compound kushen injection	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.
DRUG	palliative care group first-line scheme	FOLFOX/FOLFIRI/CAPEOX± Cetuximab/bevacizumab

Timeline

• Start date: 2023-09-27
• Primary completion: 2025-12-30
• Completion: 2025-12-31
• First posted: 2023-06-08
• Last updated: 2024-12-27

Locations

1 site across 1 country: China