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

Overview

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

Description

This study include a multi-center, randomized, parallel controlled clinical trial.The randomized clinical trial will enroll approximately 318 patients. Participants will be randomly divided into experimental (n=159) and control groups (n=159).Patients in the experimental group was treated with palliative care group first-line scheme + compound kushen injection. Patients in the control group will receive palliative care group 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.

Eligibility

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.