Four-Drug cocktail aims to shrink pancreatic tumors before surgery

NCT ID NCT04669197

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 21, 2026 · Last updated Jul 22, 2026 · Updated 1 time

Summary

This phase II trial tests whether a combination of four chemotherapy drugs—paclitaxel protein bound, gemcitabine, cisplatin, and hydroxychloroquine—given before surgery can improve outcomes for people with pancreatic cancer that has not spread. The study focuses on patients whose tumors are removable, borderline removable, or locally advanced. The main goal is to see if the treatment normalizes a key tumor marker called CA 19-9, which may indicate better 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
a combination of four drugs: paclitaxel protein bound, gemcitabine, cisplatin, and hydroxychloroquine
What this could lead to
If successful, this approach could make pancreatic tumors more removable by surgery and improve survival chances.
What could go wrong
This is an early-phase trial with only 19 participants, so results may not apply broadly. The drug combination can cause significant side effects.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

19 people

The number who actually took part.

Started

Dec 2020

Finished

Jul 2025

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Patient has histologically or cytologically confirmed resectable, borderline resectable, or locally advanced (unresectable) PDAC (based upon Tempero et al 2016) * Age ≥ 18 years. * If a female patient is of child-bearing potential, she must have a negative serum pregnancy test (≥β-hCG) documented within 72 hours of the first administration of study drug * If sexually active, the patient and partner must agree to use contraception considered adequate and appropriate by the Investigator * Patient must have received no prior chemotherapy or radiation therapy for PDAC * Patients must have normal organ and marrow function * Patient has acceptable coagulation status as indicated by an INR ≤ 1.5 x ULN. Patients on anticoagulation can be included at the discretion of the investigator. * Karnofsky Performance Status (KPS) of ≥70%. * Have an elevated CA 19-9 (\>2X ULN) in the context of normal bilirubin Exclusion Criteria: * Patient will be excluded from this study if any of the following criteria apply: Evidence of metastatic disease. No metastatic disease defined as any one or more of the following; Suspicious lymphadenopathy outside of the standard surgical field (i.e. aortocaval nodes, distant abdominal nodes) or Radiographic evidence for metastatic disease in distant organs, peritoneum, or ascites * Active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy. * Known infection with HIV, hepatitis B, or hepatitis C. * Has undergone major surgery, other than diagnostic surgery (i.e.--surgery done to obtain a biopsy for diagnosis without removal of an organ), within 4 weeks prior to Day 1 of treatment in this study. * History of allergy or hypersensitivity to the study drugs. * Serious medical risk factors involving any of the major organ systems such that the Investigator considers it unsafe for the patient to receive an experimental research drug. * Current, serious, clinically significant cardiac arrhythmias as determined by the investigator. * Patient is unwilling or unable to comply with study procedures. * Patient is enrolled in an industry sponsored clinical trial involving treatment with investigational therapy. Patients enrolled in HonorHealth sponsored research studies may be eligible to participate as long as their participation in the other research studies does not confound the data collected for this study. * Patient with a history of interstitial lung disease, history of slowly progressive dyspnea and unproductive cough, sarcoidosis, silicosis, idiopathic pulmonary fibrosis, pulmonary hypersensitivity pneumonitis or multiple allergies. * Use of non-FDA approved cannabinoids are prohibited. Total daily usage of up to 40 mg per day of marinol is acceptable. Exclusion Criteria for Hydroxychloroquine Expansion Cohort only: * Prolonged QTcF \> 450 ms for men and \> 470 ms for women at Screening. Electrolyte imbalances (e.g. hypokalemia/hypomagnesemia/hypocalcemia) must be corrected prior to first dose of hydroxychloroquine. * Known second or third degree atrioventricular block. * Patient is taking a concomitant medication that has "known" risk of QT prolongation or torsdades de pointe. * Patient has pre-existing retinopathy. * Patient has known hypersensitivity to hydroxychloroquine or other 4-aminoquinoline compounds.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Borderline resectable pancreatic adenocarcinoma are added.

Our safety recommendation!

By submitting, you agree to our Terms of use

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

  • HonorHealth Research Institute

    Scottsdale, Arizona, 85258, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.