Adenocarcinoma of the PancreasPhase 1/2NCT04911816
Neoadjuvant mFOLFIRINOX With Perioperative Oral Hydroxychloroquine in Resectable Pancreatic Adenocarcinoma
A Phase 1/2 study testing Hydroxychloroquine sulfate in people with Adenocarcinoma of the Pancreas, run by West Virginia University at 1 site in United States.
Trial summary
This will be a phase I/II trial examining the safety and tolerability of pre-operative mFOLFIRINOX in combination with peri-operative oral hydroxychloroquine (FHQ) in the treatment of subjects with adenocarcinoma of the pancreas. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adenocarcinoma of the Pancreas
- What is being tested?
- Hydroxychloroquine sulfate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Jul 2021to Jun 2030
- Phase
- Phase 1/2
- 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
- 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
Show all 10Show fewer
- 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.
Who cannot join
- 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
Show all 18Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
West Virginia University Cancer Institute Mary Babb Randolph Cancer Center
Morgantown, West Virginia, 26506
Brian Boone, MD, 3045984000, brian.boone@hsc.wvu.edu
About this study
Official title: Phase I/II Study of Neoadjuvant mFOLFIRINOX in Combination With Peri-operative Oral Hydroxychloroquine (FHQ) in Subjects With Resectable Adenocarcinoma of the Pancreas.
This will be a phase I/II trial examining the safety and tolerability of pre-operative mFOLFIRINOX in combination with peri-operative oral hydroxychloroquine (FHQ) in the treatment of subjects with adenocarcinoma of the pancreas. Subjects will be staged prior to protocol entry by contrast-enhanced helical abdominal CT scan done using a pancreas mass protocol or EUS. Eligible subjects with biopsy-proven, resectable pancreatic adenocarcinoma without evidence of venous or arterial involvement on CT scan receive HCQ orally in combination with mFOLFIRINOX prior to surgery. Hydroxychloroquine will begin with the first dose of mFOLFIRINOX and continue for 2 weeks post-operatively. Three to six weeks after the last dose of mFOLFIRINOX, patients will undergo surgical exploration and pancreatectomy if technically feasible and all toxicities have resolved. Pathologic specimens will undergo detailed histopathologic and immunohistochemical evaluations with particular attention to the six surgical margins of resection: the bile duct margin (for Whipple specimens), the margin of pancreatic transection, the retroperitoneal margin, the proximal and distal duodenal margins (for Whipple specimens), and the portal vein margin along the pancreatic head (for Whipple specimens) or medial pancreas (for distal pancreatectomies). Tissue specimens will be stored at -80C for future correlative studies of autophagy and tumor response to protocol therapy. Ten to fourteen weeks following completion of successful surgical removal of their tumor, subjects will undergo repeat staging studies per standard of care. Subjects will pursue standard of care adjuvant therapy options at the discretion of their physician.
Read the detailed description
A subject is deemed evaluable if they have received at least 3 of 4 cycles of chemotherapy and at least 80% of the expected HCQ doses and undergo successful surgical extirpation their disease. Patients will receive daily oral HCQ concurrently with neoadjuvant mFOLFIRINOX, planned for 4 cycles. Each cycle of mFOLFIRINOX is 14 days, therefore 4 cycles will occur over a period of 56 days. Oral HCQ will continue after completion of neoadjuvant chemotherapy and extend 2 weeks post-operatively. Patients will undergo restaging scans after completion of 4 cycles of mFOLFIRINOX. Within 3 to 6 weeks after completion of cycle 4 of mFOLFIRINOX, patients will proceed for surgical resection. Patients will receive surveillance scans 10 to 14 weeks after completion of surgery.
Patients will receive HCQ every day starting at the first dose of mFOLFIRINOX. Capsules of HCQ are available in 200 mg strengths. HCQ will be administered in divided doses (BID) for doses to minimize nausea. Patients should be told to swallow the whole capsule in rapid succession without chewing. The starting phase I dose for HCQ is 400 mg. Before accrual to the next dose level may begin, all patients in a given cohort must complete the 2 months of combination treatment (HCQ + mFOLFIRINOX), permitting toxicities to be assessed.
Dose will be assigned to patients using 3+3 Algorithm to identify the MTD. Dose level 1 is 400 mg hydroxychloroquine, dose level 2 is 800 mg hydroxychloroquine, and dose level 3 is 1200 mg hydroxychloroquine. If 0 first-dose DLTs are observed out of 3 patients treated with the first dose-level, the next cohort of 3 patients may be enrolled and treated at the next dose-level. If 1 out of the 3 patients treated with a dose-level experience a first-dose DLT, up to 3 additional patients (6 total) will be enrolled at that dose-level. If only 1 out of these 6 patients experiences a first-dose DLT, then the next cohort of 3 patients may be enrolled and treated at the next dose-level. If ≥2 out of these 6 patients experience first-dose DLTs, then dose escalation is stopped. Additional patients will be enrolled at the prior lower dose-level to achieve a total of 6 patients. If ≥2 out of 3 patients in a cohort experience a first-dose DLT, dose escalation will be stopped. Additional patients will be enrolled at the prior lower dose-level, to achieve a total of 6 patients. If 0 or 1 out of 3 patients at the highest dose-level (1200 mg) experiences a DLT, additional patients will be enrolled to achieve a total of 6 patients. If ≤1 out of these 6 patients experiences a DLT, the 1200mg dose-level will be declared the maximal safe dose administered in this Phase 1 study. If ≥2 patients experience a DLT, additional patients will be enrolled at the prior lower dose-level, for a total of 6 patients. If a DLT occurs in the first patient enrolled in the trial, the first cohort of six patients will be assigned to Level 1. If a cohort of six patients at Level 1 experiences more than one DLT, accrual to the trial will be paused, and the trial will be referred to the GI DSMB for appropriate action. At the conclusion of the dose escalation phase, the DSMB will meet to perform an interim review of safety data prior to establishing the maximum tolerated dose for the phase 2 phase of the trial. The maximum sample size of the study is 40 patients. Cohorts will be accrued until a new cohort would exceed the maximum study size; therefore, the final sample size will be between 35 and 40 patients.
- Conditions
- Adenocarcinoma of the Pancreas
- Being tested
- Hydroxychloroquine sulfate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydroxychloroquine sulfateDrug
Also called Plaquenil
Hydroxychloroquine, oral, dose escalated (400mg, 800mg, 1200mg) beginning concurrent with mFOLFIRINOX and extending 2 weeks post-operatively. Dose will be assigned to patients using 3+3 Algorithm to identify the Maximum Dose Tolerated.
| Study group | Role | What they receive |
|---|---|---|
| Hydroxychloroquine | Experimental | Hydroxychloroquine sulfate Receives: Drug: Hydroxychloroquine sulfate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase I - Establishing Maximum tolerated dose (MTD)
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.
Measured: From first dose to 30 days after treatment has been discontinued or until death, whichever occurs first.
Phase II - Rate of grade IIb or better histopathological response
The number of patients that have a rate of grade IIb or better histopathological response.
Measured: Up to 4 months
Secondary outcomes (1)
Phase II - To establish the potential biological activity of FHQ by biochemical tumor response, as assessed by Ca 19-9.
Treatment response will be assessed by measuring the change in the tumor marker Ca 19-9 in the serum before and after FHQ.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2021
- Study start16 Jul 2021
- Primary completionJun 2027 (estimated)
- Study completionJun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adenocarcinoma of the PancreasStudies of the same condition, open and under way.
- More trials run by West Virginia UniversityThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- West Virginia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brian Boone, MD, FACS, West Virginia University
- Investigators
- Brian Boone, MD, Principal investigator, WVU Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04911816
- Sponsor's protocol ID
- 2103260669
- Status last verified
- Apr 2026
- First submitted
- 24 May 2021
- Last updated
- 20 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I/II Study of Neoadjuvant mFOLFIRINOX in Combination With Peri-operative Oral Hydroxychloroquine (FHQ) in Subjects With Resectable Adenocarcinoma of the Pancreas.
- ClinicalTrials.gov ID
- NCT04911816
- Acronym / sponsor ID
- 2103260669
- Conditions
- Adenocarcinoma of the Pancreas
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- West Virginia UniversityUniversity, hospital or other
- Study start
- 16 Jul 2021 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2030 (estimated)
- First posted
- 3 Jun 2021 (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 will be a phase I/II trial examining the safety and tolerability of pre-operative mFOLFIRINOX in combination with peri-operative oral hydroxychloroquine (FHQ) in the treatment of subjects with adenocarcinoma of the pancreas. Subjects will be staged prior to protocol entry by contrast-enhanced helical abdominal CT scan done using a pancreas mass protocol or EUS. Eligible subjects with biopsy-proven, resectable pancreatic adenocarcinoma without evidence of venous or arterial involvement on CT scan receive HCQ orally in combination with mFOLFIRINOX prior to surgery. Hydroxychloroquine will begin with the first dose of mFOLFIRINOX and continue for 2 weeks post-operatively. Three to six weeks after the last dose of mFOLFIRINOX, patients will undergo surgical exploration and pancreatectomy if technically feasible and all toxicities have resolved. Pathologic specimens will undergo detailed histopathologic and immunohistochemical evaluations with particular attention to the six surgical margins of resection: the bile duct margin (for Whipple specimens), the margin of pancreatic transection, the retroperitoneal margin, the proximal and distal duodenal margins (for Whipple specimens), and the portal vein margin along the pancreatic head (for Whipple specimens) or medial pancreas (for distal pancreatectomies). Tissue specimens will be stored at -80C for future correlative studies of autophagy and tumor response to protocol therapy. Ten to fourteen weeks following completion of successful surgical removal of their tumor, subjects will undergo repeat staging studies per standard of care. Subjects will pursue standard of care adjuvant therapy options at the discretion of their physician.
Detailed description
A subject is deemed evaluable if they have received at least 3 of 4 cycles of chemotherapy and at least 80% of the expected HCQ doses and undergo successful surgical extirpation their disease. Patients will receive daily oral HCQ concurrently with neoadjuvant mFOLFIRINOX, planned for 4 cycles. Each cycle of mFOLFIRINOX is 14 days, therefore 4 cycles will occur over a period of 56 days. Oral HCQ will continue after completion of neoadjuvant chemotherapy and extend 2 weeks post-operatively. Patients will undergo restaging scans after completion of 4 cycles of mFOLFIRINOX. Within 3 to 6 weeks after completion of cycle 4 of mFOLFIRINOX, patients will proceed for surgical resection. Patients will receive surveillance scans 10 to 14 weeks after completion of surgery.
Patients will receive HCQ every day starting at the first dose of mFOLFIRINOX. Capsules of HCQ are available in 200 mg strengths. HCQ will be administered in divided doses (BID) for doses to minimize nausea. Patients should be told to swallow the whole capsule in rapid succession without chewing. The starting phase I dose for HCQ is 400 mg. Before accrual to the next dose level may begin, all patients in a given cohort must complete the 2 months of combination treatment (HCQ + mFOLFIRINOX), permitting toxicities to be assessed.
Dose will be assigned to patients using 3+3 Algorithm to identify the MTD. Dose level 1 is 400 mg hydroxychloroquine, dose level 2 is 800 mg hydroxychloroquine, and dose level 3 is 1200 mg hydroxychloroquine. If 0 first-dose DLTs are observed out of 3 patients treated with the first dose-level, the next cohort of 3 patients may be enrolled and treated at the next dose-level. If 1 out of the 3 patients treated with a dose-level experience a first-dose DLT, up to 3 additional patients (6 total) will be enrolled at that dose-level. If only 1 out of these 6 patients experiences a first-dose DLT, then the next cohort of 3 patients may be enrolled and treated at the next dose-level. If ≥2 out of these 6 patients experience first-dose DLTs, then dose escalation is stopped. Additional patients will be enrolled at the prior lower dose-level to achieve a total of 6 patients. If ≥2 out of 3 patients in a cohort experience a first-dose DLT, dose escalation will be stopped. Additional patients will be enrolled at the prior lower dose-level, to achieve a total of 6 patients. If 0 or 1 out of 3 patients at the highest dose-level (1200 mg) experiences a DLT, additional patients will be enrolled to achieve a total of 6 patients. If ≤1 out of these 6 patients experiences a DLT, the 1200mg dose-level will be declared the maximal safe dose administered in this Phase 1 study. If ≥2 patients experience a DLT, additional patients will be enrolled at the prior lower dose-level, for a total of 6 patients. If a DLT occurs in the first patient enrolled in the trial, the first cohort of six patients will be assigned to Level 1. If a cohort of six patients at Level 1 experiences more than one DLT, accrual to the trial will be paused, and the trial will be referred to the GI DSMB for appropriate action. At the conclusion of the dose escalation phase, the DSMB will meet to perform an interim review of safety data prior to establishing the maximum tolerated dose for the phase 2 phase of the trial. The maximum sample size of the study is 40 patients. Cohorts will be accrued until a new cohort would exceed the maximum study size; therefore, the final sample size will be between 35 and 40 patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hydroxychloroquine | Experimental | Drug: Hydroxychloroquine sulfateHydroxychloroquine sulfate |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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:
Key exclusion criteria (18 listed)
- 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).
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 |
|---|---|---|
| Hydroxychloroquine sulfateAlso: PlaquenilHydroxychloroquine, oral, dose escalated (400mg, 800mg, 1200mg) beginning concurrent with mFOLFIRINOX and extending 2 weeks post-operatively. Dose will be assigned to patients using 3+3 Algorithm to identify the Maximum Dose Tolerated. | Drug | Hydroxychloroquine |
Primary outcome
Phase I - Establishing Maximum tolerated dose (MTD)
Time frame: 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 response
Time frame: Up to 4 months
The number of patients that have a rate of grade IIb or better histopathological response.
1 secondary outcome
Phase II - To establish the potential biological activity of FHQ by biochemical tumor response, as assessed by Ca 19-9.
Time frame: 2 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 20 Apr 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.
Brian Boone, MD principal investigator
WVU Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Hydroxychloroquine sulfate in people with Adenocarcinoma of the Pancreas, run by West Virginia University at 1 site in United States.
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 10 inclusion and 18 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: looking for participants now, as of the sponsor's last update on 20 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Contact Brian Boone (304-598-4000, brian.boone@hsc.wvu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase I - Establishing Maximum tolerated dose (MTD) (time frame: From first dose to 30 days after treatment has been discontinued or until death, whichever occurs first.). The study lists 2 primary outcomes in all. 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 20 Apr 2026.