NCT05843188

Study of Hydroxychloroquine With FOLFIRI and Bevacizumab in DTP-high Metastatic Colorectal Cancer

A Phase II Study of 5-FU, Irinotecan, Bevacizumab and Hydroxychloroquine in Drug-Tolerant Persister (DTP)-Selected Patients With Metastatic Colorectal Cancer

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 155 (estimated)
• Sponsor: University Health Network, Toronto · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a two arm, 2-center, Phase II, study of 5-FU, irinotecan, bevacizumab (FOLFIRI-beva) and hydroxychloroquine (HCQ) in patients with previously untreated metastatic colorectal cancer (mCRC). Up to 155 patients will be screened for DTP-signature and up to 31 evaluable patients who are determined to be DTP-signature high will be treated with FOLFIRI-beva and HCQ. Patients will continue to receive treatments until evidence of disease progression, intolerable side effects, withdrawal of consent or death.

Conditions

• Metastatic Colorectal Cancer

Interventions

Type	Name	Description
DRUG	Hydroxychloroquine	Anti-Inflammatory - antimalarial - aminoquinolines
DRUG	Irinotecan	Antineoplastic agent
DRUG	Leucovorin	Folic acid derivative
DRUG	Fluorouracil	Antineoplastic agent
DRUG	Bevacizumab	Antineoplastic agent

Timeline

• Start date: 2023-08-09
• Primary completion: 2026-04-24
• Completion: 2026-10-24
• First posted: 2023-05-06
• Last updated: 2025-12-09

Locations

2 sites across 1 country: Canada