Trial intelligence / Profile preview

FRU-RAS

NCT07362836Phase 3

Key facts

Status: Not yet recruiting
Start: Jan 2026
Primary completion: Dec 2028
Sponsor: Fudan University
Modality: Fragment-Derived Small Molecules, Allosteric Modulators, Orthosteric Ligands

Drugs: fruquintinib
Conditions: colorectal cancer (CRC)

Overview

Phase 3, randomised, open-label trial of fruquintinib in colorectal cancer (CRC) (2 arms), sponsored by Fudan University. Primary endpoint: Progression-Free Survival at 36 months. Planned start Jan 2026; status: not yet recruiting.

Design

2 arms

Study design: RandomizedOpen-label

fruquintinib+chemotherapy
Fruquintinib combined with chemotherapy (mFOLFOX6 or FOLFIRI regimen)
bevacizumab+chemotherapy
Bevacizumab combined with chemotherapy (mFOLFOX6 or FOLFIRI regimen)

Who it enrols

Adults aged 18-75 with RAS-mutant unresectable metastatic colorectal cancer who failed first-line fluoropyrimidine-based chemotherapy, with ECOG 0-1 and adequate organ function.

Endpoints

Primary

Progression-Free Survival36 months

Secondary

Objective Response Rate24 weeks
Disease Control Rate24 weeks
Overall Survival60 months

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