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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

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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