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

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Status and phase: Enrolling; Phase 4

Conditions: Advanced Colorectal Carcinoma

Treatments: Drug: first-line scheme+compound kushen injection; Drug: palliative care group first-line scheme

Study type: Interventional

Funder types: Other

Identifiers

NCT05894694

2023-063-KY

Details and patient eligibility

About

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

Full 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.

Enrollment: 320 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 criteria

• Combined with other malignant primary tumors;

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

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

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

        • Pregnant or lactating women; women of childbearing age and their spouses can not take effective contraceptive measures during and within 6 months after the end of clinical study; ⑥ Psychiatric patients; ⑦ Patients with severe, uncontrolled organic disease or infection, such as decompensated heart, lung, kidney failure caused by intolerance to chemotherapy; ⑧ Patients who have received clinical trials of small molecule drugs within 28 days or received clinical trials of large molecule drugs within 3 months; ⑨ Patients who are known to be allergic to or intolerant of study drugs.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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320 participants in 2 patient groups

first-line scheme + compound kushen injection

Experimental group

Description:

Compound Kushen injection+first-line regimen (FOLFOX/FOLFIRI/CAPEOX± Cetuximab/bevacizumab)+

Treatment:

Drug: first-line scheme+compound kushen injection

first-line scheme

Other group

Description:

first-line regimen (FOLFOX/FOLFIRI/CAPEOX± Cetuximab/bevacizumab)

Treatment:

Drug: palliative care group first-line scheme