Untreated Resectable Pancreatic AdenocarcinomaPhase 2NCT04669197

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

A Phase 2 study testing Paclitaxel protein bound, Gemcitabine and Cisplatin in people with Untreated Resectable Pancreatic Adenocarcinoma and Borderline Resectable Pancreatic Adenocarcinoma, run by HonorHealth Research Institute at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Untreated Resectable Pancreatic Adenocarcinoma, Borderline Resectable Pancreatic Adenocarcinoma, Locally Advanced Pancreatic Adenocarcinoma
What is being tested?: Paclitaxel protein bound, Gemcitabine and Cisplatin
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 19 participants
Where: 1 siteUnited States
Study dates: 1 Dec 2020to 31 Jul 2025
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

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

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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

Who cannot join

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.

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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.

Trial locations and contacts

1 site in 1 country.

United States1 site

HonorHealth Research Institute
Scottsdale, Arizona, 85258

Other trials in United States

About this study

Official title: 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

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

Conditions: Untreated Resectable Pancreatic Adenocarcinoma, Borderline Resectable Pancreatic Adenocarcinoma, Locally Advanced Pancreatic Adenocarcinoma
Being tested: Paclitaxel protein bound, Gemcitabine, Cisplatin, Hydroxychloroquine

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Paclitaxel protein boundDrug
combination therapy
GemcitabineDrug
combination therapy
CisplatinDrug
combination therapy
HydroxychloroquineDrug
combination therapy

Study groups in NCT04669197
Study group	Role	What they receive
Treatment	Other	Paclitaxel Protein Bound + Gemcitabine + Cisplatin + Hydrochloroquine Receives: Drug: Paclitaxel protein bound; Drug: Gemcitabine; Drug: Cisplatin; Drug: Hydroxychloroquine

What is being measured

The primary outcome is the main question the study is designed to answer.

CA 19-9 Normalization
Laboratory measurements of CA 19-9, a circulating tumor biomarker, were collected on Day 1 of every treatment cycle (approximately 21 days/cycle); CA 19-9 normalization after 2 or more treatment cycles was measured.
Measured: From enrollment to the end of study, up to 30 weeks.

Secondary outcomes (7)

Resectability Rate (R0)
The percentage of participants whose tumors could be completely removed by surgery after receiving study regimen with no cancer cells left at margins (R0).
Measured: After end of treatment, from 6 months up to 2 years.
Pathologic Complete Response Rate (pCR)
Pathological complete response rate (pCR) is defined here as the absence of detectable cancer after surgical resection. Participants received a CT/MRI scan after surgical resection to monitor response using RECIST 1.1 criteria.
Measured: After end of treatment, from 6 months up to 2 years.
Radiological Response - Complete Response (CR) or Partial Response (PR)
Objective measurement of changes in tumor size upon imaging after treatment per RECIST v1.1 criteria; percentage of participants reporting Complete Response (CR; all tumors disappear) and Partial Response (PR; >30% decrease in tumor size).
Measured: From enrollment to end of study, up to 30 weeks.
Radiological Response - All Responses
Objective measurement of changes in tumor size upon imaging after treatment per RECIST v1.1 criteria. Complete Response (CR; all tumors disappeared), Partial Response (PR; >30% decrease in tumor size), Stable Disease (SD; no change), and Progressive Disease (PD; >20% increase in tumor size or new lesions).
Measured: From enrollment to the end of study, up to 30 weeks.
2-Year Survival
Participants were contacted by telephone every 12 weeks to monitor survival until date of death. Participants surviving up to 2 years are reported.
Measured: 2 years after study completion
Overall Survival
Participants were contacted by telephone every 12 weeks to monitor survival until date of death.
Measured: Every 12 weeks from study entry, up to 32 months.
Adverse Events Related to Study Agents
The number of patients who experienced an adverse event (AE) determined to be related to one or more of the study agents. Adverse events occurring were graded according to the NCI Common Terminology Criteria for Adverse Events v4.0 (CTCAE). Grade refers to the severity of the AE and are given on a 1-5 scale, with each scale having unique clinical descriptions of severity for each AE based on this general guideline:
Grade 1: Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated.
Grade 2: Moderate; minimal, local or noninvasive intervention indicated. Grade 3: Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling.
Grade 4: Life-threatening consequences; urgent intervention indicated. Grade 5: Death related to AE.
Measured: From enrollment to end of study, up to 30 weeks.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Dec 202031 Jul 2025

First posted16 Dec 2020
Study start1 Dec 2020
Primary completion21 Feb 2024
Study completion31 Jul 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Untreated Resectable Pancreatic AdenocarcinomaStudies of the same condition, open and under way.
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 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 19 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04669197
Sponsor's protocol ID: HCQ NABPLAGEM-NEO 2020
Status last verified: Apr 2026
First submitted: 1 Dec 2020
Last updated: 21 Jul 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Undecided

Study at a glance

From the registry record, last updated by the sponsor on 21 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT04669197
Acronym / sponsor ID: HCQ NABPLAGEM-NEO 2020
Conditions: Untreated Resectable Pancreatic Adenocarcinoma, Borderline Resectable Pancreatic Adenocarcinoma, Locally Advanced Pancreatic Adenocarcinoma
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 19 participants (actual)
Lead sponsor: HonorHealth Research InstituteUniversity, hospital or other
Study start: 1 Dec 2020 (actual)
Primary completion: 21 Feb 2024 (actual)
Study completion: 31 Jul 2025 (actual)
First posted: 16 Dec 2020 (actual)
Results: Posted 21 Jul 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Treatment	Other	Drug: Paclitaxel protein bound, Drug: Gemcitabine, Drug: Cisplatin, Drug: HydroxychloroquinePaclitaxel Protein Bound + Gemcitabine + Cisplatin + Hydrochloroquine

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

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

Key exclusion criteria (17 listed)

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.

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
Paclitaxel protein boundcombination therapy	Drug	Treatment
Gemcitabinecombination therapy	Drug	Treatment
Cisplatincombination therapy	Drug	Treatment
Hydroxychloroquinecombination therapy	Drug	Treatment

Primary outcome

CA 19-9 Normalization
Time frame: From enrollment to the end of study, up to 30 weeks.
Laboratory measurements of CA 19-9, a circulating tumor biomarker, were collected on Day 1 of every treatment cycle (approximately 21 days/cycle); CA 19-9 normalization after 2 or more treatment cycles was measured.

7 secondary outcomes

Resectability Rate (R0)
Time frame: After end of treatment, from 6 months up to 2 years.
Pathologic Complete Response Rate (pCR)
Time frame: After end of treatment, from 6 months up to 2 years.
Radiological Response - Complete Response (CR) or Partial Response (PR)
Time frame: From enrollment to end of study, up to 30 weeks.
Radiological Response - All Responses
Time frame: From enrollment to the end of study, up to 30 weeks.
2-Year Survival
Time frame: 2 years after study completion
Overall Survival
Time frame: Every 12 weeks from study entry, up to 32 months.
Adverse Events Related to Study Agents
Time frame: From enrollment to end of study, up to 30 weeks.

Results and safety

Results posted to the registry on 21 Jul 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Treatment	19	12

Primary outcome: CA 19-9 Normalization

Time frame: From enrollment to the end of study, up to 30 weeks.. Number (95% Confidence Interval). Unit: Percentage of participants

Measure	Treatment n = 11
Non-responder (< 50%)	9.1 (0.2 to 41.3)
Minor responder (50-89%)	18.2 (2.3 to 51.8)
Major responder (> 89%)	72.7 (39.0 to 94.0)
Normalized (< 35 U/mL)	36.4 (10.9 to 69.2)

Population analysed: n=1 participant failed to complete a full cycle of treatment and was deemed non-evaluable.

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were assessed from enrollment through 30 days post-study, up to 30 weeks. Deaths were assessed from enrollment until end of follow-up, up to 32 months.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Treatment	7 of 12 (58.3%)	12 of 12 (100%)	11 of 12

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Undecided

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. This study is not recruiting at the moment.

Erkut Borazanci, MD principal investigator

HonorHealth Research Institute

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 9 inclusion and 17 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: finished, as of the sponsor's last update on 21 Jul 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 phase mean?

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?

Yes. Results are posted in the registry (first posted 21 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

CA 19-9 Normalization (time frame: From enrollment to the end of study, up to 30 weeks.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04669197.

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 21 Jul 2026.