Study of mFOLFIRINOX with Hydroxychloroquine for Pancreatic Cancer
This study is testing a combination of treatments for resectable pancreatic adenocarcinoma (a type of pancreatic cancer that can be removed by surgery). You would receive mFOLFIRINOX chemotherapy along with an oral medication called hydroxychloroquine sulfate before surgery. The study aims to find the safest dose of hydroxychloroquine sulfate and see how well this combination shrinks the tumor before surgery. We are looking for 40 participants aged 18 or older who have pancreatic adenocarcinoma that can be surgically removed and meet other health criteria. The study is currently unclear on its recruitment status.
- Study design
- This is a Phase I/II study, meaning it first looks at safety and then at effectiveness. It plans to enroll 40 participants.
- What's involved
- You would receive mFOLFIRINOX chemotherapy for 4 cycles (56 days) and take oral hydroxychloroquine daily, continuing for 2 weeks after surgery. You will have scans before and after treatment, and again 10-14 weeks after surgery.
- Compensation
- Not stated in the trial record.
- Follow-up
- You will have surveillance scans 10 to 14 weeks after surgery.
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NCT04911816
Neoadjuvant mFOLFIRINOX With Perioperative Oral Hydroxychloroquine in Resectable Pancreatic Adenocarcinoma
Recruiting
PHASE1Ages 18+InterventionalTreatmentWest Virginia UniversityInvestigator-initiated
~40 participants
Updated 2026-04-20 on ClinicalTrials.gov
What's tested:Hydroxychloroquine sulfate
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Phase I - Establishing Maximum tolerated dose (MTD)
Measured over From first dose to 30 days after treatment has been discontinued or until death, whichever occurs first.
+1 more outcome measured
Conditions
Where it's being run
1 sites across 1 statesWest Virginia1
Study leadership
- Brian Boone, MD · PRINCIPAL_INVESTIGATOR · WVU Cancer Institute
Who to contact
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Do you actually qualify for this trial?
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Eligibility criteria
Inclusion
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
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.
What this trial measures
- Phase I - Establishing Maximum tolerated dose (MTD)From first dose to 30 days after treatment has been discontinued or until death, whichever occurs first.
Maximum tolerated dose (MTD) for FHQ which is defined as the highest dose level in which the investigators have treated 6 patients with at most 1 experiencing dose limiting toxicities (DLT). A maximum of 18 patients (3x6) will be accrued for dose finding.
- Phase II - Rate of grade IIb or better histopathological responseUp to 4 months
The number of patients that have a rate of grade IIb or better histopathological response.