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Study of Hydroxychloroquine With FOLFIRI and Bevacizumab in DTP-high Metastatic Colorectal Cancer
Sponsor: University Health Network, Toronto
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.
Official title: A Phase II Study of 5-FU, Irinotecan, Bevacizumab and Hydroxychloroquine in Drug-Tolerant Persister (DTP)-Selected Patients With Metastatic Colorectal Cancer
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
155
Start Date
2023-08-09
Completion Date
2026-10-24
Last Updated
2025-12-09
Healthy Volunteers
No
Conditions
Interventions
Hydroxychloroquine
Anti-Inflammatory - antimalarial - aminoquinolines
Irinotecan
Antineoplastic agent
Leucovorin
Folic acid derivative
Fluorouracil
Antineoplastic agent
Bevacizumab
Antineoplastic agent
Locations (2)
Sunnybrook Odette Cancer Centre
Toronto, Ontario, Canada
Princess Margaret Cancer Centre
Toronto, Ontario, Canada