NCT04296019

Fruquintinib as a Maintenance Therapy Following First-line Treatment for Metastatic Colorectal Cancer

A Randomized, Open-label, Multicenter, Phase II Clinical Study Evaluating the Efficacy and Safety of Fruquintinib as a Maintenance Therapy Following First-line Treatment for Metastatic Colorectal Cancer

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 110 (estimated)
• Sponsor: Shanghai Zhongshan Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study was a randomized, controled, multicenter, phase II clinical study evaluating the efficacy and safety of fruquintinib as a maintenance therapy following first-line treatment for metastatic colorectal cancer. This study will include the patients with confirmed unresectable metastatic left-sided colon cancer with RAS mutation or right-sided colon cancer who achieved stable disease (SD) or partial response (PR) or complete response (CR) via palliative first-line treatment. It's expected to include 110 patients and they will be randomly stratified at 2:1 into fruquintinib group and observation group based on whether bevacizumab is used and the primary tumor site, using the Interactive Network Response System (IWRS). The random No. corresponds to the respective patient. The enrollment time is expected to be 18 months, followed up for 24 months.

Conditions

• Colo-rectal Cancer

Interventions

Type	Name	Description
DRUG	Fruquintinib	Maintenance therapy with fruquintinib ( 5 mg qd for 3 consecutive weeks, followed by discontinuation for 1 week).

Timeline

• Start date: 2021-02-01
• Primary completion: 2023-07-01
• Completion: 2025-01-01
• First posted: 2020-03-05
• Last updated: 2021-11-03

Locations

1 site across 1 country: China