Could an old malaria drug boost cancer treatment?
NCT ID NCT05843188
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether adding hydroxychloroquine (a malaria drug) to standard chemotherapy can help people with metastatic colorectal cancer that has a specific genetic marker. About 155 participants will be screened, and up to 31 with the marker will receive the drug combination. The goal is to see if the tumors shrink and how long the benefits last.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
About 155 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Aug 2023
- Expected to finish
-
Dec 2026
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Histologically confirmed colorectal cancer, not amenable to curative resection. * Microsatellite stable/mismatch repair proficient (MSS/pMMR) colorectal cancer. * No prior systemic therapy for metastatic disease. * Evaluable disease based on RECIST 1.1 criteria. * Adequate hematological, hepatic and renal functions * Eastern Cooperative Oncology Group (ECOG) Performance status 0-1. * Estimated life expectancy of \> 6 months. * Negative pregnancy test for female patients with child-bearing potential. * No history of retinal disorder. * No history of glucose-6-phosphate dehydrogenase deficiency (G6PD) . * Considered to be DTP-signature high to receive HCQ treatment Exclusion Criteria: * Women who are pregnant or nursing. * Have received radiotherapy, chemotherapy, biological therapy, or investigational treatment less than four weeks (six weeks for nitrosoureas or mitomycin C) prior to first dose of FOLFIRI-beva or have not recovered from all acute toxicities from prior treatments to grade 1 or less, with the exception of alopecia and those deemed not to affect safety assessment. * Have concurrent malignancy with exception of malignancy that was treated curatively and without evidence of recurrence within 3 years of study enrollment, or fully resected basal or squamous cell skin cancer and any carcinoma in situ which are considered to be of low risk of recurrence. * Have had major surgery within 28 days of study enrollment. Placement of a venous access device within 28 days of starting therapy is allowed. * Have any medical condition that would impair the administration of oral agents including significant bowel resection, inflammatory bowel disease or uncontrolled nausea or vomiting. * Known central nervous system metastasis. Patients with history of central nervous system metastases are eligible if they are clinically and radiographically stable for at least 3 months and not taking steroids or anticonvulsants.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Metastatic colorectal cancer are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Princess Margaret Cancer Centre
Toronto, Ontario, M5G2M9, Canada
-
Sunnybrook Odette Cancer Centre
Toronto, Ontario, M4N 3M5, Canada
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a hyaluronic acid drug combo outperform bevacizumab in Hard-to-Treat colon cancer?
- Can a targeted drug boost chemotherapy in advanced colorectal cancer?
- New antibody aims to preserve immune checkpoint while fighting cancer
- Two-Step PET scan aims to spot hidden colorectal cancer spread
- Can a targeted drug conjugate outsmart advanced colorectal cancer?
- Can an antimalarial drug boost immunotherapy against colorectal cancer?