NCT06427005

Fruquintinib Plus S-1 and Raltitrexed (RSF) for MCRC

Fruquintinib Combined with S-1 and Raltitrexed for Patients with Metastatic Colorectal Cancer Refractory to Standard Therapies: a Phase II Study

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 66 (estimated)
• Sponsor: Meng Qiu · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Based on the FRECO-2 study, Fruquintinib has become one of the standard third-line treatments for advanced colorectal cancer; however, its objective response rate (ORR) remains low. Our previous studies have shown that the combination of raltitrexed and S-1 -/+ bevacizumab is effective and provides a significant survival benefit in patients with metastatic colorectal cancer (mCRC) who are refractory to standard treatments. This study aims to evaluate the efficacy and safety of combining Fruquintinib with S-1 and raltitrexed in these patients.

Detailed description

Conducted at West China Hospital in China, this investigator-initiated, open-label, single-arm, phase II trial included patients with mCRC that had progressed following treatment with fluoropyrimidine, irinotecan, and oxaliplatin, and had at least one measurable lesion. Patients could have previously received anti-EGFR (for tumors with wild-type RAS) and anti-VEGF therapy in the first or second line, including those who had been treated with bevacizumab in two consecutive chemotherapy regimens. Participants received Fruquintinib (5 mg daily for 14 days followed by a 7-day break), oral S-1 (80-120 mg daily for 14 days, followed by a 7-day break), and raltitrexed (3 mg/m² on day 1, with a maximum dose of 5 mg) every 3 weeks. The primary endpoint was the ORR, while secondary endpoints included progression-free survival (PFS), overall survival (OS), and toxicity.

Conditions

• Fruquintinib
• S-1
• Raltitrexed

Interventions

Type	Name	Description
DRUG	Fruquintinib	Fruquintinib 5 mg daily for 14 days followed by a 7-day break
DRUG	S-1	S-1 80-120 mg daily for 14 days, followed by a 7-day break
DRUG	raltitrexed	raltitrexed 3 mg/m² on day 1, with a maximum dose of 5 mg

Timeline

• Start date: 2023-02-20
• Primary completion: 2025-08-18
• Completion: 2026-04-30
• First posted: 2024-05-23
• Last updated: 2025-01-22

Locations

2 sites across 1 country: China