New drug cocktail targets pancreatic Cancer's defenses before surgery
NCT ID NCT05365893
First seen Jun 27, 2026 ยท Last updated Jun 27, 2026
Summary
This study tests whether a combination of three drugs (paricalcitol, hydroxychloroquine, and losartan) can safely modify the supportive tissue around pancreatic tumors before surgery. About 20 adults with resectable pancreatic cancer will take these drugs for at least 4 weeks between standard chemotherapy/radiation and their operation. The goal is to see if this approach is feasible and does not delay surgery.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Early phase 1
The earliest testing in people: a first look at safety, in a very small group.
- Participants
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20 people
The number who actually took part.
- Started
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Oct 2021
- Expected to finish
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Dec 2026
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 for all study participants: * Patients must have new diagnosed histologically or cytologically confirmed pancreatic adenocarcinoma. * Patients must have resectable non-metastatic PDAC and anticipate receiving surgery in a minimum of 4 weeks and a maximum of 12 weeks from completing neoadjuvant chemotherapy and radiation. * Patients are planned for a minimum of 3 months of modified FOLFIRINOX treatment followed by chemo/radiation followed by surgical resection. * Age \> 18 years. * ECOG performance status 0-1 * Patients must have normal organ function as defined below * Total bilirubin within normal institutional limits * AST/ALT (SGOT/SGPT) \< 5 times institutional normal limits * Creatinine within normal institutional limits OR * Creatinine clearance \> 30 Ml/min/1.73 m2 for patients with creatinine levels above institutional normal * Women of childbearing potential must be non-pregnant (negative pregnancy test within 72 hours prior to registration). Postmenopausal woman must have been amenorrhoeic and nonlactating for at least 12 months to be considered of non-childbearing potential. Men and women of child bearing potential must be willing to exercise an effective form of birth control (abstinence/contraception) while on study and for 3 months after therapy is completed. * Ability to understand and willingness to sign a written informed consent and HIPAA consent document Exclusion Criteria for all study participants: * Tumors of acinar or adenocarcinoma histology * Patients may not be receiving any other investigational agents * Patients currently receiving hydroxychloroquine or an angiotensin II receptor blocker * Patients with radiological or cytologically confirmed metastatic or unresectable disease * Pregnant or breast feeding. Refer to section 4.4 for further detail. Inclusion criteria for participation in experimental PHL therapy (Arm A): * Patients must have resectable non-metastatic PDAC and anticipate receiving surgery in a minimum of 4 weeks and a maximum of 12 weeks from completing neoadjuvant chemotherapy and chemoradiation. * Patients completed a minimum of 3 months of modified FOLFIRINOX treatment followed by chemoradiation prior to study enrollment and plans for surgical resection. * Ability to understand and willingness to sign a written informed consent and HIPAA consent document Exclusion Criteria for participation in Experimental PHL Therapy (Arm A): * Patients who have residual grade 3 or higher adverse events from prior chemotherapy or chemoradiotherapy for pancreatic cancer * Concomitant use of an ACE inhibitor or ARB, vitamin D, or hydroxychloroquine. Patient may elect to stop Vitamin D supplement and will be allowed to enroll on the study. * Patients cannot have a history of retinopathy, macular degeneration or other severe ocular issues, baseline hypotension (systolic blood pressure lower than 100 mmHg on two separate readings obtained on two separate days), or history of hypercalcemia requiring treatment * Patients with known disorders precluding use of any of the study drugs including a history of angioedema, hypotension, or renal disease (CrCl \< 30mL/min). * History of allergic reactions attributed to compound of similar chemical or biologic composition to the agent(s) used in this study * Patients receiving any medications or substances that significantly interact with PHL are ineligible (specified in section 5.2). * A marked baseline prolongation of QT/QTc interval * A history of additional risk factors for Torsades de Pointes (e.g., heart failure, family history of Long QT Syndrome) * Atrio-ventricular blockade of 2nd or 3rd degree * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. * Pregnant or breast feeding.
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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.
Contacts and locations
Locations
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Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111, United States
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Other studies related to the condition(s) this trial covers.
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