drugset / Trial / NCT05522738

Safety and Efficacy of Fruquintinib+FOLFIRI in RAS-mutated Metastatic Colorectal Cancer

NCT05522738

NaSingle-groupOpen-labelTreatment

Summary

Molecular subtypes make difference on clinicopathologic features and response to chemotherapy and targeted agents as well as prognosis. RAS mutation status, which accounting for approximately 35% to 40% of colorectal cancer patients, is an important factor considered in the standard of care for colorectal cancer. For RAS-mutated patients, no targeted driver gene drugs have been approved, and their treatment is based on the anti-VEGF/VEGFR pathway, and corresponding targeted drugs such as bevacizumab, aflibercept, and ramucirumab have also been successfully marketed for the treatment of CRC. For RAS mutant metastatic colorectal cancer, the commonly used first-line treatment regimen is bevacizumab combined with chemotherapy, which is shown in previous studiesthat the PFS of 1st-line is about 10 months; the standard regimen of second-line treatment is FOLFIRI ± bevacizumab, which is shown in previous study that the 2nd-line PFS is about 5 months with ORR 4%. There are a lot of unmet medical needs to improve the clinical efficacy in secondline-treatment of RAS-mutant patients.

Timeline

Start
2022-08-10
Primary completion
2024-12
Completion
2025-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Fruquintinib Small molecule 3 mg Oral
Subject Fruquintinib Small molecule 4 mg Oral
Subject Fruquintinib Small molecule 5 mg Oral
Background Combination: Fruquintinib + FOLFIRI Unknown 200 mg/m2 Intravenous
Background Irinotecan Small molecule 180 mg/m2 Intravenous
Background fluorouracil Small molecule 2400 mg/m2 Intravenous

Indications