NCT05843188Active, not recruitingPhase 2
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
Source: ClinicalTrials.gov · Last updated 22 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 155 (estimated)
- First submitted
- 29 Mar 2023
- Start date
- 9 Aug 2023
- Primary completion date
- 24 Dec 2026
- Lead sponsor
- University Health Network, Toronto
- Diseases
- Colorectal cancer
- NCT number
- NCT05843188
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 155
- From 9 Aug 2023 to the primary completion date, 24 Dec 2026
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- 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.
Other
- Women who are pregnant or nursing.
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Sunnybrook Odette Cancer Centre Coordinator of this site? Confirm its status | Toronto | Canada | Unknown status |
| Princess Margaret Cancer Centre Coordinator of this site? Confirm its status | Toronto | Canada | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.