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Trial Title:
Survival Benefit of Compound Kushen Injection in the Treatment of Advanced Colorectal Cancer
NCT ID:
NCT05894694
Condition:
Advanced Colorectal Carcinoma
Conditions: Official terms:
Colorectal Neoplasms
Conditions: Keywords:
Compound kushen Injection
Traditional Chinese medicine
Study type:
Interventional
Study phase:
Phase 4
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
palliative care group first-line scheme+compound kushen injection
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.
Arm group label:
palliative care group first-line scheme + compound kushen injection
Intervention type:
Drug
Intervention name:
palliative care group first-line scheme
Description:
FOLFOX/FOLFIRI/CAPEOX± Cetuximab/bevacizumab
Arm group label:
palliative care group first-line scheme
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.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Guang 'anmen Hospital, China Academy of Chinese Medical Sciences
Address:
City:
Beijing
Country:
China
Status:
Recruiting
Contact:
Last name:
Jie Li
Start date:
June 11, 2023
Completion date:
December 30, 2024
Lead sponsor:
Agency:
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Agency class:
Other
Source:
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05894694
