Fruquintinib Plus FOLFIRI in RAS-mutated Metastatic Colorectal Cancer
Colorectal Cancer
About this trial
This is an interventional treatment trial for Colorectal Cancer focused on measuring Fruquintinib, RAS-mutant, second-line
Eligibility Criteria
Inclusion Criteria: Histological or cytological confirmed colorectal cancer; RAS mutation; Expected survival >12 weeks; Patients had disease progression during or within 3 months of the last dose of first-line therapy, which must include bevacizumab combined with oxaliplatin, and a fluoropyrimidine; 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: MSI-H / dMMR; Received radiation therapy, surgical procedure, immunotherapy or other investigational drugs within 4 weeks prior to treatment ; Prior treatment with anti-angiogenic small molecule targeted drugs, such as fruquintinib, etc; Prior treatment with an irinotecan-based chemotherapy regimen; 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.
Sites / Locations
- Hunan Cancer hospital
Arms of the Study
Arm 1
Experimental
study group
Fruquintinib combined with FOLFIRI