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

NCT ID: NCT05894694

Last Updated: 2024-12-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

320 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-27

Study Completion Date

2025-12-31

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 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.

Conditions

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Advanced Colorectal Carcinoma

Keywords

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Compound kushen Injection Traditional Chinese medicine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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first-line scheme + compound kushen injection

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

Group Type EXPERIMENTAL

first-line scheme+compound kushen injection

Intervention Type DRUG

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.

first-line scheme

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

Group Type OTHER

palliative care group first-line scheme

Intervention Type DRUG

FOLFOX/FOLFIRI/CAPEOX± Cetuximab/bevacizumab

Interventions

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first-line scheme+compound kushen injection

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.

Intervention Type DRUG

palliative care group first-line scheme

FOLFOX/FOLFIRI/CAPEOX± Cetuximab/bevacizumab

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Guang'anmen Hospital of China Academy of Chinese Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Jie Li

Vice President

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Guang 'anmen Hospital, China Academy of Chinese Medical Sciences

Beijing, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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jie Li

Role: CONTACT

Phone: 88001711

Email: [email protected]

Facility Contacts

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Jie Li

Role: primary

References

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Wu J, Ge Y, Zhu G, Gao R, Zhu X, Zhang Y, Li J. Combination of Compound Kushen injection with first-line treatment versus first-line treatment alone for advanced colorectal cancer: a study protocol for a multicenter, openlabel, randomized controlled trial. BMC Complement Med Ther. 2024 Dec 31;24(1):429. doi: 10.1186/s12906-024-04725-6.

Reference Type DERIVED
PMID: 39741233 (View on PubMed)

Other Identifiers

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2023-063-KY

Identifier Type: -

Identifier Source: org_study_id