NCT05004831

Fruquintinib Combined With TAS-102 in the Treatment of Patients With Advanced Metastatic CRC

Phase II Study of Fruquintinib Combined With TAS-102 in the Treatment of Patients With Advanced Metastatic CRC

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 54 (estimated)
• Sponsor: Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This phase II study aims to explore the efficacy and safety of fruquintinib combined with TAS-102 in the third-line treatment of patients with advanced metastatic colorectal cancer.

Detailed description

This is a prospective, single center, one-arm phase II study. A total of 54 advanced mCRC patients refractory to standard therapies will be enrolled and administered with fruquintinib (4mg/d, qd po, D1-21, Q4W) combined with TAS-102 (70mg/m2/d, bid po, D1-5, 8-12, Q4W) until intolerable toxicity, disease progression or death. Primary endpoint of this study is PFS and secondary endpoints are OS, ORR, DCR and safety.

Conditions

• Metastatic Colorectal Cancer

Interventions

Type	Name	Description
DRUG	fruquintinib plus TAS-102	fruquintinib 4mg/d, qd po, D1-21, Q4W; TAS-102 70mg/m2/d, bid po, D1-5, 8-12, Q4W

Timeline

• Start date: 2022-03-11
• Primary completion: 2023-09-01
• Completion: 2024-09-01
• First posted: 2021-08-13
• Last updated: 2022-08-18

Locations

1 site across 1 country: China