Metastatic colorectal cancer
Conditions
Interventions
Single-arm group:Xianjunfang Granules combined with Western medicine standard treatment protocol.
Sponsors
China Academy of Traditional Chinese Medicine, Xiyuan Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: (1) Age 18-80 years, gender; (2) Diagnosed with colorectal cancer by pathology, clinical stage IV, with genetic testing showing MSS or immunohistochemistry showing pMMR; (3) Patients with mCRC who are about to receive or have received third-line or higher systemic treatment within less than 1 month; (4) Meet the diagnostic criteria for the syndrome of yang deficiency of spleen and kidney in traditional Chinese medicine; (5) ECOG score 0-2; (6) Expected survival =3 months; (7) Have measurable lesions according to the RECIST 1.1 criteria; (8) No severe abnormalities in heart, lung, liver, or kidney function; (9) Normal coagulation function, no active bleeding or thrombotic diseases; (10) Voluntarily join this study and sign the informed consent form; (11) Expected to have good compliance, able to follow up on efficacy and adverse reactions as required by the protocol; (12) The investigator believes the patient can benefit from this treatment plan.
Exclusion criteria
Exclusion criteria: (1) Patients with brain metastases presenting clinical symptoms; (2) Patients with other untreated or incurable malignant tumors; (3) Patients with dMMR by immunohistochemistry or MSI-H by genetic testing; (4) Patients with uncontrolled hypertension, where blood pressure cannot be reduced to normal levels despite antihypertensive therapy (systolic =140 mmHg/diastolic =90 mmHg); (5) Patients with uncontrolled cardiac clinical symptoms or diseases, such as: a. NYHA Class II or higher heart failure; b. Unstable angina; c. Myocardial infarction within the past year; d. Clinically significant supraventricular or ventricular arrhythmias requiring clinical intervention; (6) Patients with multiple factors affecting oral drug absorption, such as inability to swallow or intestinal obstruction; (7) Patients at risk of bleeding, including: a. Active peptic ulcer lesions; b. History of melena or hematemesis within the past 3 months; c. Hemoptysis within 1 month prior to entering the study; (8) Patients with thrombotic diseases or receiving anticoagulant therapy; requiring long-term anticoagulation with warfarin or heparin, or long-term antiplatelet therapy (aspirin =300 mg/day or clopidogrel =75 mg/day); (9) Patients who have undergone major surgery, open biopsy, or significant trauma within 28 days prior to enrollment; (10) Patients currently participating in or planning to participate in other clinical trials; (11) Other situations deemed unsuitable for inclusion by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Survival (OS); | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease Control Rate (DCR);Progression-Free Survival; | — |
Countries
China
Contacts
Public ContactZhang Tong
China Academy of Traditional Chinese Medicine, Xiyuan Hospital
Outcome results
None listed