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
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
320 participants
Sep 27, 2023
INTERVENTIONAL
Conditions
Summary
To clarify the effectiveness and safety of compound kushen injection in the treatment of advanced colorectal cancer.
Eligibility
Inclusion Criteria1
- 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 Criteria5
- 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.
Interventions
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.
FOLFOX/FOLFIRI/CAPEOX± Cetuximab/bevacizumab
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT05894694