Metastatic Colorectal CancerPhase 2NCT05843188
Study of Hydroxychloroquine With FOLFIRI and Bevacizumab in DTP-high Metastatic Colorectal Cancer
A Phase 2 study testing Hydroxychloroquine, Irinotecan and Leucovorin in people with Metastatic Colorectal Cancer, run by University Health Network, Toronto at 2 sites in Canada.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Colorectal Cancer
- What is being tested?
- Hydroxychloroquine, Irinotecan and Leucovorin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 155 participants
- Where
- 2 sitesCanada
- Study dates
- 9 Aug 2023to 24 Dec 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Sunnybrook Odette Cancer Centre
Toronto, Ontario, M4N 3M5
Princess Margaret Cancer Centre
Toronto, Ontario, M5G2M9
About this study
Official title: A Phase II Study of 5-FU, Irinotecan, Bevacizumab and Hydroxychloroquine in Drug-Tolerant Persister (DTP)-Selected Patients With Metastatic Colorectal Cancer
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
- Being tested
- Hydroxychloroquine, Irinotecan, Leucovorin, Fluorouracil, Bevacizumab
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anti-Inflammatory - antimalarial - aminoquinolines
IrinotecanDrug
Antineoplastic agent
LeucovorinDrug
Also called Folinic acid
Folic acid derivative
FluorouracilDrug
Also called 5-FU
Antineoplastic agent
BevacizumabDrug
Antineoplastic agent
| Study group | Role | What they receive |
|---|---|---|
| High DTP-signature | Experimental | Take HCQ, 400 mg by mouth, twice daily. Receive FOLFIRI+bevacizumab (irinotecan 180 mg/m2, leucovorin 400 mg/m2, 5-FU 2400 mg/m2 over 46 - 48 hours, bevacizumab 5 mg/kg), intravenously, every 2 weeks Receives: Drug: Hydroxychloroquine; Drug: Irinotecan; Drug: Leucovorin; Drug: Fluorouracil; Drug: Bevacizumab |
| Low DTP-signature | Active comparator | Receive FOLFIRI+bevacizumab (irinotecan 180 mg/m2, leucovorin 400 mg/m2, 5-FU 2400 mg/m2 over 46 - 48 hours, bevacizumab 5 mg/kg), intravenously, every 2 weeks Receives: Drug: Irinotecan; Drug: Leucovorin; Drug: Fluorouracil; Drug: Bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall response rate
Percentage of participants who have a partial response or complete response to study treatment.
Measured: Start of study treatment to end of study, up to 48 months.
Secondary outcomes (3)
Progression-free survival
Average length of time that participants' diseases do not worsen.
Measured: Start of study treatment to time of disease progression, up to 48 months.
Overall survival
Average length of time that participants are alive.
Measured: Start of study treatment to time of death, up to 48 months.
Incidences and severity of adverse events
Number of adverse events per grade
Measured: Start of study treatment to end of study, up to 48 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2023
- Study start9 Aug 2023
- Primary completion24 Dec 2026 (estimated)
- Study completion24 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Colorectal CancerStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 155 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eric Chen, MD, Principal investigator, Princess Margaret Cancer Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05843188
- Sponsor's protocol ID
- Targeting DTP in mCRC
- Other IDs
- 22-5689
- Status last verified
- Jun 2026
- First submitted
- 29 Mar 2023
- Last updated
- 22 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of 5-FU, Irinotecan, Bevacizumab and Hydroxychloroquine in Drug-Tolerant Persister (DTP)-Selected Patients With Metastatic Colorectal Cancer
- ClinicalTrials.gov ID
- NCT05843188
- Acronym / sponsor ID
- Targeting DTP in mCRC
- Conditions
- Metastatic Colorectal Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 155 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- 9 Aug 2023 (actual)
- Primary completion
- 24 Dec 2026 (estimated)
- Study completion
- 24 Dec 2026 (estimated)
- First posted
- 6 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High DTP-signature | Experimental | Drug: Hydroxychloroquine, Drug: Irinotecan, Drug: Leucovorin, Drug: Fluorouracil, Drug: BevacizumabTake HCQ, 400 mg by mouth, twice daily. Receive FOLFIRI+bevacizumab (irinotecan 180 mg/m2, leucovorin 400 mg/m2, 5-FU 2400 mg/m2 over 46 - 48 hours, bevacizumab 5 mg/kg), intravenously, every 2 weeks |
| Low DTP-signature | Active comparator | Drug: Irinotecan, Drug: Leucovorin, Drug: Fluorouracil, Drug: BevacizumabReceive FOLFIRI+bevacizumab (irinotecan 180 mg/m2, leucovorin 400 mg/m2, 5-FU 2400 mg/m2 over 46 - 48 hours, bevacizumab 5 mg/kg), intravenously, every 2 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HydroxychloroquineAnti-Inflammatory - antimalarial - aminoquinolines | Drug | High DTP-signature |
| IrinotecanAntineoplastic agent | Drug | High DTP-signature, Low DTP-signature |
| LeucovorinAlso: Folinic acidFolic acid derivative | Drug | High DTP-signature, Low DTP-signature |
| FluorouracilAlso: 5-FUAntineoplastic agent | Drug | High DTP-signature, Low DTP-signature |
| BevacizumabAntineoplastic agent | Drug | High DTP-signature, Low DTP-signature |
Primary outcome
Overall response rate
Time frame: Start of study treatment to end of study, up to 48 months.
Percentage of participants who have a partial response or complete response to study treatment.
3 secondary outcomes
Progression-free survival
Time frame: Start of study treatment to time of disease progression, up to 48 months.
Overall survival
Time frame: Start of study treatment to time of death, up to 48 months.
Incidences and severity of adverse events
Time frame: Start of study treatment to end of study, up to 48 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric Chen, MD principal investigator
Princess Margaret Cancer Centre
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Hydroxychloroquine, Irinotecan and Leucovorin in people with Metastatic Colorectal Cancer, run by University Health Network, Toronto at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 22 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall response rate (time frame: Start of study treatment to end of study, up to 48 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2026.