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

Last updated: December 21, 2024
Sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Overall Status: Active - Recruiting

Phase

4

Condition

N/A

Treatment

first-line scheme+compound kushen injection

palliative care group first-line scheme

palliative care group first-line scheme+compound kushen injection

Clinical Study ID

NCT05894694
2023-063-KY
  • Ages > 18
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

① Patients with advanced CRC confirmed by pathology or cytology and receiving first-line therapy;② Aged ≥ 18 years old, male or female;③ ECOG score 0-2 points;④ Expected survival ≥ 3 months;⑤ According to RECIST1.1 criteria, at least one detectable lesion;⑥ Voluntarily join the study, sign informed consent, compliance with good cooperation with follow-up.

Exclusion

Exclusion Criteria:

  • Combined with other malignant primary tumors;

  • Immunohistochemistry/polymerase chain reaction/second-generation sequencingresults suggest MSI-H/dMMR patients;

  • Patients with recurrence and metastasis within 6 months after radicaltumor surgery;

  • Patients who have previously or are undergoing cancer immunotherapy ;Patients undergoing radiation therapy;

  • Pregnant or lactating women; women of childbearing age and theirspouses can not take effective contraceptive measures during andwithin 6 months after the end of clinical study; ⑥ Psychiatricpatients; ⑦ Patients with severe, uncontrolled organic diseaseor infection, such as decompensated heart, lung, kidney failurecaused by intolerance to chemotherapy; ⑧ Patients who havereceived clinical trials of small molecule drugs within 28 daysor received clinical trials of large molecule drugs within 3months; ⑨ Patients who are known to be allergic to or intolerantof study drugs.

Study Design

Total Participants: 320
Treatment Group(s): 3
Primary Treatment: first-line scheme+compound kushen injection
Phase: 4
Study Start date:
September 27, 2023
Estimated Completion Date:
December 31, 2025

Study 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.

Connect with a study center

  • Guang 'anmen Hospital, China Academy of Chinese Medical Sciences

    Beijing,
    China

    Active - Recruiting

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