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Survival Benefit of Compound Kushen Injection in the Treatment of Advanced Colorectal Cancer | Clinical Trials | Clareo Health

RECRUITINGPHASE4

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

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

NCT05894694•Guang'anmen Hospital of China Academy of Chinese Medical Sciences

View on ClinicalTrials.gov

Summary

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

Detailed 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.

Eligibility

Age

18 - No limit years

Sex

ALL

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.

Locations (1)

Guang 'anmen Hospital, China Academy of Chinese Medical Sciences

Beijing, China

Key Dates

Start Date

September 27, 2023

Primary Completion Date

December 30, 2025

Completion Date

December 31, 2025

Last Updated

December 27, 2024

Enrollment

320

ESTIMATED participants

Conditions

Advanced Colorectal Carcinoma

Interventions

first-line scheme+compound kushen injection

DRUG

palliative care group first-line scheme

DRUG

Contacts

jie Li

CONTACT

88001711 qfm2020jieli@yeah.net

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 27, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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