NCT06118762

Clinical Study of Fruquintinib Combined With Raltitrexed in the Treatment of Metastatic Colorectal Cancer

A Single-arm, Open, Multicenter Clinical Study of Fruquintinib Combined With Raltitrexed in the Treatment of Metastatic Colorectal Cancer

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: The First Affiliated Hospital of Nanchang University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the efficacy and safety of Fruquintinib combined with Raltitrexed in the treatment of metastatic colorectal cancer that progressed or could not be tolerated after previous fluorouracil, oxaliplatin, and irinotecan based therapy

Detailed description

To evaluate the progression-free survival (PFS), objective response rate (ORR), disease control rate (DCR), overall survival (OS), and safety of Fruquintinib combined with Raltitrexed in 30 patients with metastatic colorectal cancer who had progressed or could not tolerate fluorouracil, oxaliplatin, and irinotecan based therapy.

Conditions

• Metastatic Colorectal Cancer

Interventions

Type	Name	Description
DRUG	Fruquintinib	Fruquintinib capsule is taken orally once a day, 5 mg each time, and taken for 2 weeks and stopped for 1 week, every 21 days (3 weeks) for a cycle. Raltitrexed: 3 mg/m2 intravenously, on the first day of each cycle, for a treatment cycle of 3 weeks. Combination treatment until toxicity becomes intolerable, disease progression, or death.

Timeline

• Start date: 2023-10-20
• Primary completion: 2026-10-01
• Completion: 2026-10-01
• First posted: 2023-11-07
• Last updated: 2023-11-07

Locations

1 site across 1 country: China