Back to resultsSurvival Benefit of Compound Kushen Injection in the Treatment of Advanced Colorectal Cancer
Primary Purpose
Advanced Colorectal Carcinoma
Status
Recruiting
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
palliative care group first-line scheme+compound kushen injection
palliative care group first-line scheme
Sponsored by
About this trial
This is an interventional treatment trial for Advanced Colorectal Carcinoma focused on measuring Compound kushen Injection, Traditional Chinese medicine
Eligibility Criteria
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.
Sites / Locations
- Guang 'anmen Hospital, China Academy of Chinese Medical SciencesRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
palliative care group first-line scheme + compound kushen injection
palliative care group first-line scheme
Arm Description
palliative care group first-line regimen (FOLFOX/FOLFIRI/CAPEOX± Cetuximab/bevacizumab)+ compound kushen injection
palliative care group first-line regimen (FOLFOX/FOLFIRI/CAPEOX± Cetuximab/bevacizumab)
Outcomes
Primary Outcome Measures
PFS
Progression Free Survival
Secondary Outcome Measures
OS
Overall survival
1-year survival rate
The probability of patients surviving more than 1 year after treatment
1-year PFS rate
Refers to the proportion of patients with tumor progression or death since enrollment of treatment.
Full Information
NCT ID
NCT05894694
First Posted
April 24, 2023
Last Updated
June 7, 2023
Sponsor
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT05894694
Brief Title
Survival Benefit of Compound Kushen Injection in the Treatment of Advanced Colorectal Cancer
Official Title
Survival Benefit of Compound Kushen Injection in Treatment of Advanced Colorectal Cancer Based on Real World Registration Platform
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 11, 2023 (Anticipated)
Primary Completion Date
December 30, 2024 (Anticipated)
Study Completion Date
December 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Colorectal Carcinoma
Keywords
Compound kushen Injection, Traditional Chinese medicine
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
318 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
palliative care group first-line scheme + compound kushen injection
Arm Type
Experimental
Arm Description
palliative care group first-line regimen (FOLFOX/FOLFIRI/CAPEOX± Cetuximab/bevacizumab)+ compound kushen injection
Arm Title
palliative care group first-line scheme
Arm Type
Other
Arm Description
palliative care group first-line regimen (FOLFOX/FOLFIRI/CAPEOX± Cetuximab/bevacizumab)
Intervention Type
Drug
Intervention Name(s)
palliative care group first-line scheme+compound kushen injection
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
palliative care group first-line scheme
Intervention Description
FOLFOX/FOLFIRI/CAPEOX± Cetuximab/bevacizumab
Primary Outcome Measure Information:
Title
PFS
Description
Progression Free Survival
Time Frame
The time from randomization to tumor progression or death in patients, whichever came first, assessed up to 100 months
Secondary Outcome Measure Information:
Title
OS
Description
Overall survival
Time Frame
The time from randomization to death from any cause after enrollment, whichever occurs first, assessed up to 100 months
Title
1-year survival rate
Description
The probability of patients surviving more than 1 year after treatment
Time Frame
The proportion of patients with survival period of more than 1 year accounted for the total patients from the beginning of enrollment treatment
Title
1-year PFS rate
Description
Refers to the proportion of patients with tumor progression or death since enrollment of treatment.
Time Frame
The proportion of patients with tumor progression or death from enrollment.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
jie Li
Phone
88001711
Email
qfm2020jieli@yeah.net
Facility Information:
Facility Name
Guang 'anmen Hospital, China Academy of Chinese Medical Sciences
City
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jie Li
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Survival Benefit of Compound Kushen Injection in the Treatment of Advanced Colorectal Cancer
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