NCT05522738

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

Prospective, Single-arm, Single-center Phase Ib/II Trial on the Safety and Efficacy of Fruquintinib in Combination With FOLFIRI in RAS-mutated Metastatic Colorectal Cancer

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 46 (estimated)
• Sponsor: Chinese PLA General Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a prospective, single-armed, single-center phase Ib/II study to investigate the safety and efficacy of Fruquintinib combined with FOLFIRI in RAS-mutant patients who failed first-line standard therapy.

Conditions

• Metastatic Colorectal Cancer

Interventions

Type	Name	Description
DRUG	Combination: Fruquintinib + FOLFIRI	Phase 1b Fruquintinib was administered in a 3 + 3 dose escalation regimen at the following doses: L1:3 mg/d, L2:4 mg/d, L3:5 mg/d. Fruquintinib: QD po q2w FOLFIRI regimen: Irinotecan：180 mg/m2, i.v. , d1, q2w LV：200 mg/m2, i.v., d1, q2w 5-FU：2400 mg/m2, i.v.for over 46 hours, q2w Phase II Fruquintinib: RP2D, QD po q2w FOLFIRI regimen: Irinotecan： 180 mg/m2, i.v. , d1, q2w LV： 200 mg/m2, i.v., d1, q2w 5-FU：2400 mg/m2, i.v.for over 46 hours, q2w

Timeline

• Start date: 2022-08-10
• Primary completion: 2024-12-01
• Completion: 2025-12-01
• First posted: 2022-08-31
• Last updated: 2024-01-08

Locations

1 site across 1 country: China