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

• Status: Not yet recruiting
• Trial end date: 2025-12-01
• Target enrollment: 0
• Participant gender: All

Summary

RAS mutations are found in nearly half of colorectal cancer patients. However, there is no targeted driver gene drugs have been approved for RAS-mutated patients. For RAS mutant metastatic colorectal cancer, the commonly used treatment regimen is bevacizumab combined with chemotherapy.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fudan University

Criteria

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.