Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Phase
Phase 4
Started
2023-09-27
Last updated
2024-12-27
Condition(s) studied
Advanced Colorectal Carcinoma
Investigational drug(s) / intervention(s)
first-line scheme+compound kushen injectionpalliative care group first-line scheme
first-line scheme+compound kushen injection: 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.
palliative care group first-line scheme: FOLFOX/FOLFIRI/CAPEOX± Cetuximab/bevacizumab
Study summary
To clarify the effectiveness and safety of compound kushen injection in the treatment of advanced colorectal cancer.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.
Primary outcome measure(s)
PFS — The time from randomization to tumor progression or death in patients, whichever came first, assessed up to 24 months Progression Free Survival
Trial sites (1)
Facility
City
Region
Status
Guang 'anmen Hospital, China Academy of Chinese Medical Sciences
Beijing
China
Recruiting
More Guang'anmen Hospital of China Academy of Chinese Medical Sciences trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time on our Cookie Policy page. See also our Privacy Policy.