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Tucidinostat + Sintilimab + Bevacizumab vs Fruquintinib in MSS/pMMR Colorectal Cancer

NCT06497985Phase 3

Key facts

Status: Recruiting
Start: Dec 2024
Primary completion: May 2028
Countries: 1
Sponsor: Akeso, Inc.
Modality: Small Molecules

Drugs: tucidinostat
Conditions: colorectal cancer (CRC)

Overview

Phase 3, randomised, open-label trial of tucidinostat in colorectal cancer (CRC) (2 arms), sponsored by Akeso, Inc. Primary endpoint: Overall Survival at 2 years. Started Dec 2024; status: recruiting.

Design

2 arms

Study design: RandomizedOpen-label

tucidinostat+sintilimab+bevacizumab
Tucidinostat 30mg orally BIW + Sintilimab 200 mg IV Q3W + Bevacizumab 7.5mg/kg IV Q3W
fruquintinib
Fruquintinib 5mg orally QD

Who it enrols

Patients with unresectable and metastatic colorectal adenocarcinoma who failed at least second-line standard therapies (including fluoropyrimidine, irinotecan, and oxaliplatin), with confirmed MSS/MSI-L/pMMR, known KRAS status, ECOG PS 0-1, and expected survival >12 weeks. Excludes prior use of HDAC inhibitors, immune checkpoint inhibitors, or small-molecule VEGFR TKIs.

Endpoints

Primary

Overall Survival2 years

Secondary

Progression Free Survival2 years
Overall Response Rate2 years
Duration of Response2 years
Disease Control Rate2 years
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 Global Health Status/Quality of Life Scale2 years
EuroQoL 5 Dimension 5 Level Health Utility Index2 years
EuroQoL 5 Dimension 5 Level Visual Analog Scale2 years
Safety and Tolerability2 years

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