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

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

Detailed Description
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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.

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

Conditions
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Advanced Colorectal Carcinoma

Intervention / Treatment
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* Drug: palliative care group first-line scheme+compound kushen injection
* Drug: palliative care group first-line scheme


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: palliative care group first-line scheme + compound kushen injection<br>palliative care group first-line regimen (FOLFOX/FOLFIRI/CAPEOX± Cetuximab/bevacizumab)+ compound kushen injection | Drug: palliative care group first-line scheme+compound kushen injection<br>* 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, at least 4 cycles of chemotherapy.<br>|
| Other: palliative care group first-line scheme<br>palliative care group first-line regimen (FOLFOX/FOLFIRI/CAPEOX± Cetuximab/bevacizumab) | Drug: palliative care group first-line scheme<br>* FOLFOX/FOLFIRI/CAPEOX± Cetuximab/bevacizumab<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PFS | Progression Free Survival | The time from randomization to tumor progression or death in patients, whichever came first, assessed up to 100 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| OS | Overall survival | The time from randomization to death from any cause after enrollment, whichever occurs first, assessed up to 100 months | 
| 1-year survival rate | The probability of patients surviving more than 1 year after treatment | The proportion of patients with survival period of more than 1 year accounted for the total patients from the beginning of enrollment treatment | 
| 1-year PFS rate | Refers to the proportion of patients with tumor progression or death since enrollment of treatment. | The proportion of patients with tumor progression or death from enrollment. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Compound kushen Injection, Traditional Chinese medicine