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Survival Benefit of Compound Kushen Injection in the Treatment of Advanced Colorectal Cancer
RECRUITINGPhase 4Sponsored by Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Actively Recruiting
PhasePhase 4
SponsorGuang'anmen Hospital of China Academy of Chinese Medical Sciences
Started2023-09-27
Est. completion2025-12-30
Eligibility
Age18 Years+
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT05894694
Summary
To clarify the effectiveness and safety of compound kushen injection in the treatment of advanced colorectal cancer.
Eligibility
Age: 18 Years+Healthy volunteers accepted
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.Conditions2
Advanced Colorectal CarcinomaCancer
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Actively Recruiting
PhasePhase 4
SponsorGuang'anmen Hospital of China Academy of Chinese Medical Sciences
Started2023-09-27
Est. completion2025-12-30
Eligibility
Age18 Years+
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT05894694