Could a malaria drug boost chemo for pancreatic cancer?
NCT ID NCT04911816
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether adding hydroxychloroquine (a malaria drug) to standard chemotherapy before surgery can improve outcomes for people with resectable pancreatic cancer. About 40 participants will receive the drug combo, then undergo surgery to remove their tumor. The goal is to find a safe dose and see if the treatment shrinks tumors enough to improve surgical results.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- hydroxychloroquine (Plaquenil) plus mFOLFIRINOX chemotherapy
- What this could lead to
- If it works, this could point toward a more effective treatment approach for resectable pancreatic cancer, potentially improving surgical outcomes and survival.
- What could go wrong
- This is an early-phase trial with only 40 participants, so results may not apply broadly. Hydroxychloroquine can cause side effects like vision problems and heart issues, and the combination may not improve outcomes over standard chemo alone.
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
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 40 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2021
- Expected to finish
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Jun 2030
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 * Subjects with biopsy-proven adenocarcinoma of the pancreas * Pancreatic protocol helical CT scan demonstrating absence of venous or arterial involvement, consistent with NCCN guidelines for resectable disease * ECOG performance status ≤ 1 * No active second malignancy except for basal cell carcinoma of the skin * Normal renal, hepatic, and hematologic function at the time of enrollment as evidenced by: * Serum creatinine level ≤1.5 the upper limits of normal * Serum total bilirubin level ≤1.5 X ULN * White blood cell count ≥ 3.5x109/ml per ml and platelet count ≥ 100x109 per ml * For subjects with obstructive jaundice, the biliary tract must be drained with a temporary plastic or a short permanent metallic biliary stent * Ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria * Subjects deemed surgically unresectable or subjects unwilling to undergo surgical resection. * Subjects who have received chemotherapy within 12 months prior to study entry. * Subjects who are found to have loss-of-function mutations in DPYD or UGTA1 by Oneome pharmacogenomic testing, resulting in increased risk of mFOLFIRINOX toxicity. DPYD mutations have been noted in 5% of the overall population. Homozygous UGT1A1 mutations have been noted in 10% of North Americans. * Prior use of radiotherapy or investigational agents for pancreatic cancer. * Any evidence of metastasis to distant organs (liver, lung, peritoneum). * Cross sectional imaging suggesting portal vein, superior mesenteric artery, hepatic artery involvement that would make the patient borderline resectable or locally advanced * Symptomatic or endoscopic evidence of gastric outlet obstruction. * Concurrent malignancies with evidence of active or measurable disease except basal cell carcinoma of the skin. * Inability to adhere to study and/or follow-up procedures. * History of allergic reactions or hypersensitivity to the study drugs (chloroquine, hydroxychloroquine, 5-Fluorouracil, Leucovorin, Oxaliplatin, Irinotecan). * Other concurrent experimental therapy. * The effects of HCQ, and mFOLFIRINOX on the developing human fetus are unknown. For this reason women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. All females of childbearing potential must have a blood test or urine study within two weeks prior to registration to rule out pregnancy. Should a woman become pregnant while participating in this study, she should inform her treating physician immediately. If a man impregnates a woman while participating in this study, he should inform his treating physician immediately as well. * Because patients with immune deficiency are at increased risk of lethal infections when treated with bone marrow-suppressive therapy, HIV-positive patients are excluded from the study. For patients receiving combination anti-retroviral therapy, the potential impact of pharmacokinetic interactions with HCQ and mFOLFIRINOX is unknown. Appropriate studies may be undertaken in patients with HIV and those receiving combination anti-retroviral therapy in the future. * Due to the risk of disease exacerbation, patients with porphyria are ineligible. * Patients with psoriasis are ineligible unless the disease is well controlled and they are under the care of a specialist who agrees to monitor the patient for exacerbations. * Patients requiring the use of enzyme-inducing anti-epileptic medication that includes: phenytoin, carbamazepine, phenobarbital, primidone or oxcarbazepine are excluded. * Patients with previously documented macular degeneration or diabetic retinopathy are excluded. * Baseline EKG with QTc \>470 msec (including subjects on medication). Subjects with ventricular pacemaker for whom QT interval is not measurable will be eligible on a case-by-case basis.
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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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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West Virginia University Cancer Institute Mary Babb Randolph Cancer Center
RECRUITINGMorgantown, West Virginia, 26506, United States
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Other studies related to the condition(s) this trial covers.
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- New radiation approach aims to tame tough pancreatic tumors