NCT06099314

Fruquintinib in the Cross-line Treatment of Refractory mCRC

A Real-world Study of Fruquintinib in the Cross-line Treatment of Refractory mCRC

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 36 (estimated)
• Sponsor: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: —

Summary

This is a real-world study. Patients with metastatic colorectal cancer who have progressed (PD) after third-line treatment with fruquintinib combined with PD-1 inhibitors will receive fruquintinib combined with TAS-102 as fourth-line therapy. The objective of this study was to observe the efficacy and safety of cross-line（from third to fourth line）treatment with fruquinitinib.

Detailed description

This is a real-world study. Patients with metastatic colorectal cancer confirmed by histopathology had previously received 2-line system therapy with fluorouracil, oxaliplatin, irinotecan, anti-VEGF, anti-EGFR (RAS and BRAF wild type) (treatment with anti-VEGF-TKI is not allowed), and had received fruquinitinib combined with PD-1 inhibitors for third-line treatment. After progression (PD) (confirmed by RECIST 1.1 ), fruquinitinib combined with TAS-102 as fourth-line therapy was received. The primary endpoint was observation the overall survival (OS) of fourth-line treatment of mCRC with fruquinitinib and TAS-102. The study objective is to explore the possibility of cross-line rechallenge of fruquinitinib.

Conditions

• Fruquintinib
• Metastatic Colorectal Cancer

Interventions

Type	Name	Description
DRUG	Fruquintinib+PD-1 inhibitors	Third-line treatment with fruquintinib combined with PD-1 inhibitors. Fruquintinib: 5mg,Oral once daily,2 weeks on/1 week off,Q3W； PD-1 inhibitor：for example, Sintilimab,iv,200mg, Q3W.
DRUG	Fruquintinib+TAS-102	Fourth-line treatment with fruquintinib combined with TAS-102 . Fruquintinib: 3-5mg(Depending on the patient's physical condition), Oral once daily,3 weeks on/1 week off,Q4W； TAS-102:orally, 35mg/m2 twice daily (maximum dose 80mg in a single dose) for days 1-5, repeated every 14 days.

Timeline

• Start date: 2023-10-01
• Primary completion: 2025-09-01
• Completion: 2025-09-01
• First posted: 2023-10-25
• Last updated: 2023-10-25

Locations

3 sites across 1 country: China