Fruquintinib Plus FOLFIRI in RAS-mutated Metastatic Colorectal Cancer (NCT05842525) | Clinical Trial Compass
UnknownPhase 2
Fruquintinib Plus FOLFIRI in RAS-mutated Metastatic Colorectal Cancer
China42 participantsStarted 2023-10-01
Plain-language summary
RAS mutations are found in nearly half of colorectal cancer patients. However, except for G12C mutation, no driven gene targeted drug can be used. the commonly first-line used treatment regimen is bevacizumab combined with chemotherapy. Angiogenesis is an important therapeutic target in colorectal carcinoma. Fruquintinib is an oral small molecule inhibitor of VEGFR1/2/3, has approved for the third-line treatment of refractory colorectal cancer.
Who can participate
Age range18 Years – 75 Years
SexALL
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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;