The Efficacy and Safety of Fruquintinib Plus FOLFIRI/FOLFOX as Second-line Treatment in Patients With RAS-mutant Metastatic Colorectal Cancer

Inclusion Criteria:

* ≥18 years
* Histological or cytological confirmed colorectal cancer;
* RAS mutation
* Expected survival \>12 weeks;
* Fail in previous standard therapy, which must include FOLFOX/FOLFIRI;
* ECOG PS 0-1;
* At least one measurable lesion (according to RECIST1.1);
* Adequate hepatic, renal, heart, and hematologic functions;
* Negative serum pregnancy test at screening for women of childbearing potential.

Exclusion Criteria:

* Received other investigational drugs within 4 weeks prior to treatment;
* Prior treatment with anti-angiogenic small molecule targeted drugs, such as fruquintinib, etc;
* Symptomatic brain or meningeal metastases (except for patients with BMS who have received local radiotherapy or surgery for more than 6 months and whose disease is stable);
* Severe infection (e.g., requiring intravenous antibiotics, antifungal drugs, or antiviral drugs) within 4 weeks prior to treatment;
* Patients with hypertension that cannot be well controlled by antihypertensive medication (systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg);
* Patients who had active bleeding or coagulopathy within 2 months before enrollment, had a tendency to bleed, or were receiving thrombolytic therapy and were considered by the investigator to be ineligible for enrollment;
* Active heart disease, including myocardial infarction, severe/unstable angina, 6 months prior to treatment. Echocardiography examination left ventricular ejection fraction \< 50%, arrhythmia control is not good;
* The patient has had other malignant tumors within 5 years (except cured basal cell carcinoma of the skin and carcinoma in situ of the cervix);
* Allergy to the study drug or any of its excipients;
* The patient is unable to take the drug orally, or the patient has a condition judged by the investigator to affect the absorption of the drug;
* Women who are pregnant (with a positive pregnancy test before medication) or breastfeeding;
* Urine routine showed urine protein ≥2+, and 24-hour urine protein level \>1.0g;
* Other conditions deemed by the investigator to be ineligible for inclusion in the study.