Survival Benefit of Compound Kushen Injection in the Treatment of Advanced Colorectal Cancer

Recruiting · NCT05894694 · Interventional (participants receive a specific treatment)

Interventions studied

first-line scheme+compound kushen injectionpalliative care group first-line scheme

To clarify the effectiveness and safety of compound kushen injection in the treatment of advanced colorectal cancer.

Age range

18 Years and older

Sex

All (male and female)

Healthy volunteers

No - a diagnosis or condition is required

Phase

Phase 4

Study type

Interventional (participants receive a specific treatment)

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.

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.

1 location listed.

Guang 'anmen Hospital, China Academy of Chinese Medical Sciences - Beijing, China