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

• Status: Recruiting
• Trial end date: 2024-12-30
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Criteria

Inclusion Criteria:

• Patients with initially unresectable metastatic colorectal cancer confirmed by pathology or cytology;

• Age ≥18 years old, male or female; ③ECOG score 0-2;

• Predicted survival ≥4 months;

• at least one detectable lesion according to RECIST1.1 criteria; ⑥ Join the study voluntarily, sign the informed consent, good compliance with follow-up.

Exclusion Criteria:

• Patients with primary tumors of other sites;

• Immunohistochemical/polymerase chain reaction/second-generation sequencing results suggested MSI-H/dMMR patients;

• Patients who have received or are receiving tumor immunotherapy or radiotherapy;

• Pregnant or lactating women;

• Women of childbearing age and their spouses cannot take effective contraceptive measures during the clinical study period and within 6 months after the end of the study; ⑥ Mental patients;

• Patients with severe, uncontrolled organic disease or infection, such as decompensated heart, lung, renal failure, etc., that can not tolerate chemotherapy;

• Patients who have received small molecule drug clinical trials within 28 days or large molecule drug clinical trials within 3 months; ⑨ Patients with known allergy to or intolerance to the study drug.