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

Advanced Colorectal Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05894694
• Other study ID #: 2023-063-KY
• Status: Recruiting
• Phase: Phase 4
• Start date: June 11, 2023
• Est. completion date: December 30, 2024

Study information

• Verified date: June 2023
• Source: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
• Contact: jie Li
• Phone: 88001711
• Email: qfm2020jieli[@]yeah.net
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 318
• Est. completion date: December 30, 2024
• Est. primary completion date: December 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients with initially unresectable metastatic colorectal cancer confirmed by pathology or cytology;
• Age =18 years old, male or female; ?ECOG score 0-2;
• Predicted survival =4 months;
• at least one detectable lesion according to RECIST1.1 criteria; ? 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; ? 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; ? Patients with known allergy to or intolerance to the study drug.

Related Conditions & MeSH terms

• Advanced Colorectal Carcinoma
• Colorectal Neoplasms

Intervention

Drug:
• palliative care group 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, at least 4 cycles of chemotherapy.
• palliative care group first-line scheme
FOLFOX/FOLFIRI/CAPEOX± Cetuximab/bevacizumab

Locations

Country	Name	City	State
China	Guang 'anmen Hospital, China Academy of Chinese Medical Sciences	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PFS	Progression Free Survival	The time from randomization to tumor progression or death in patients, whichever came first, assessed up to 100 months
Secondary	OS	Overall survival	The time from randomization to death from any cause after enrollment, whichever occurs first, assessed up to 100 months
Secondary	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
Secondary	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.