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Study of Paclitaxel Protein Bound + Gemcitabine + Cisplatin + Hydrochloroquine as Treatment in Untreated Pancreas Cancer | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITINGPHASE2

Study of Paclitaxel Protein Bound + Gemcitabine + Cisplatin + Hydrochloroquine as Treatment in Untreated Pancreas Cancer

A Phase II Study of Paclitaxel Protein Bound + Gemcitabine + Cisplatin+ Hydroxychlororoquine as Preoperative Treatment in Patients With Untreated Resectable, Borderline Resectable and Locally Advanced Adenocarcinoma of the Pancreas

NCT04669197•HonorHealth Research Institute

View on ClinicalTrials.gov

Summary

To evaluate the normalization rate of CA 19-9 of individuals with non-metastatic pancreas cancer following up to 6 months of neoadjuvant chemotherapy.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.
+6 more criteria

Locations (1)

HonorHealth Research Institute

Scottsdale, Arizona, United States

Key Dates

Start Date

December 1, 2020

Primary Completion Date

February 21, 2024

Completion Date

December 30, 2025

Last Updated

August 15, 2025

Enrollment

ACTUAL participants

Conditions

Untreated Resectable Pancreatic AdenocarcinomaBorderline Resectable Pancreatic AdenocarcinomaLocally Advanced Pancreatic Adenocarcinoma

Interventions

Paclitaxel protein bound

DRUG

Gemcitabine

DRUG

Cisplatin

DRUG

Hydroxychloroquine

DRUG

Studying Chemotherapy With or Without Panitumumab for Unresectable, Locally Advanced, or Metastatic Pancreatic Cancer Without KRAS Mutations

NCT06998940

Locally Advanced Pancreatic AdenocarcinomaMetastatic Pancreatic Adenocarcinoma+3 more

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RECRUITINGPHASE2

Photoradiation With Verteporfin to Facilitate Immunologic Activity of Pembrolizumab in Unresectable, Locally Advanced or Metastatic Pancreatic Cancer

NCT06381154

Locally Advanced Pancreatic AdenocarcinomaMetastatic Pancreatic Adenocarcinoma+4 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 15, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Study of Paclitaxel Protein Bound + Gemcitabine + Cisplatin + Hydrochloroquine as Treatment in Untreated Pancreas Cancer

Inclusion Criteria

Exclusion Criteria

Studying Chemotherapy With or Without Panitumumab for Unresectable, Locally Advanced, or Metastatic Pancreatic Cancer Without KRAS Mutations

Photoradiation With Verteporfin to Facilitate Immunologic Activity of Pembrolizumab in Unresectable, Locally Advanced or Metastatic Pancreatic Cancer

Neoadjuvant Chemotherapy for Borderline Resectable and Locally Advanced Pancreatic Adenocarcinoma

Stereotactic Body Radiation and Tumor Treating Fields for Locally Advanced Pancreas Cancer

Surgery for Locally Unresectable Pancreatic Cancer

Standard or Prolonged Neoadjuvant Chemotherapy Before Surgery for BR/LAPC