A clinical study on the efficacy and safety of warming Yang and dredging intestines method in the maintenance phase of metastatic colorectal cancer

Not Applicable

Conditions: colorectal cancer

Registration Number: ITMCTR2024000229

Lead Sponsor: Xi yuan Hospital of CACMS

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

(1) patients aged 18-80, gender not limited, (2) pathologically diagnosed with colorectal cancer with clinical stage IV, (3) those who intended to receive maintenance therapy after criteria according to NCCN or CSCO colorectal cancer guidelines, (4) those with Eastern Cooperative Oncology Group (ECOG) score of 0-2, (5) those with expected survival =3 months, (6)those with measurable lesions according to RECIST 1.1 criteria, (7)those with no severe cardiac, pulmonary, hepatic, or renal function abnormalities, (8) those with normal coagulation function, no active bleeding or thrombotic disorders, (9) those who voluntary participation in the study, signed informed consent, (10) those who expected good compliance, able to follow-up on efficacy and adverse reactions as required by the protocol.

Exclusion Criteria

(1) patients with clinical symptoms of brain metastases, (2)those with other untreated malignancies, (3)those with dMMR for immunohistochemistry or MSI-H for genetic testing, (4) those with uncontrollable hypertension, (5) those with uncontrollable clinical cardiac symptoms or disease, (6) those with multiple factors that affect the absorption of oral medications, such as inability to swallow and intestinal obstruction (7)those at risk of bleeding, including the following: a. active peptic ulcer lesions; b. history of black stools and vomiting of blood within 3 months; c. hemoptysis within 1 month before study entry; (8) those who have major surgery, open biopsy, or significant trauma within 28 days before enrollment, (9) those who will be, or are, participating in other clinical trials (10) those who with other conditions such as pregnancy that researchers consider unsuitable for inclusion.