Losartan and Hypofractionated Rx After Chemo for Tx of Borderline Resectable or Locally Advanced Pancreatic Cancer (SHAPER) (SHAPER)

May 7, 2026 updated by: University of Utah

SHAPER: A Phase 1 Study of Losartan and Hypofractionated Radiation Therapy After Induction Chemotherapy for Borderline Resectable or Locally Advanced Pancreatic Cancer

This phase I trial studies the side effects of losartan and hypofractionated radiation therapy after chemotherapy in treating patients with pancreatic cancer that may or may not be removed by surgery (borderline resectable) or has spread from its original site of growth to nearby tissues or lymph nodes and is not amenable to surgical resection (locally advanced unresectable). Losartan may improve blood flow and allows for better tissue oxygenation. Hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter period of time and may kill more tumor cells and have fewer side effects. Giving losartan and hypofractionated radiation therapy may work better in treating patients with pancreatic cancer compared to hypofractionated radiation therapy alone.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Beginning day 1, patients receive losartan potassium orally (PO) once daily (QD). Beginning day 14, patients also undergo hypofractionated radiation therapy over 15 fractions 5 days a week for up to 3 weeks. Patients continue to receive losartan potassium PO QD during radiation therapy and for 28 days after completion of radiation therapy.

After completion of study treatment, patients are followed up at 28 and 84 days, every 3 months for 12 months, and then every 6 months for up to 36 months.

Study Type

Interventional

Enrollment (Actual)

22

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Utah
      • Salt Lake City, Utah, United States, 84112
        • Huntsman Cancer Institute/University of Utah

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Male or female subject aged ≥ 18 years.
  • Histologically confirmed pancreatic ductal adenocarcinoma.
  • Borderline resectable or locally advanced unresectable pancreas cancer as defined by the National Comprehensive Cancer Network (NCCN) and determined by a pancreatic surgeon prior to therapy. This can be confirmed by the surgeon's documentation in the electronic medical record, by a treatment planning conference note, or by the signature of a pancreatic surgeon.
  • At least one infusion of FOLFIRINOX, NALIRIFOX, or gemcitabine based chemotherapy must have been attempted.
  • No more than 6 months of chemotherapy as defined by standard cycle lengths (every other week infusions for FOLFIRINOX or NALIRIFOX, and 3 infusions per month for gemcitabine-based therapy). Each infusion of FOLFIRINOX or NALIRIFOX will be counted as 0.5 months. Three infusions of gemcitabine based chemotherapy will be counted as 1 month. If chemotherapy is given over a protracted period, then more than 6 months of chemotherapy may be acceptable. For example, if gemcitabine-based therapy is given every other week, then each infusion will still only count as 1/3 of a month toward the 6 month total. If a partial cycle of chemotherapy is given, that partial cycle will be counted proportional to the amount given. For example, if one of three planned infusions of gemcitabine based chemotherapy is given, it will be counted as 1/3 month.
  • Enrollment must occur within 90 days of Day 1 of the last infusion given of chemotherapy. Patients who have primary tumor or regional lymph node.

progression on chemotherapy or prior to enrollment are eligible if no distant metastases are identified on the screening imaging assessment.

  • Eastern Cooperative Oncology Group (ECOG) performance status =< 1
  • Absolute neutrophil count (ANC) >= 1500/uL
  • Platelets >= 100k/uL
  • Total Bilirubin =< 2.0 mg/dL
  • Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 x institutional upper limit of normal (ULN)
  • Serum creatinine < 1.25 md/dL
  • Serum potassium < 5.0 mmol/L
  • Negative serum or urine pregnancy test at screening for women of childbearing potential
  • Highly effective contraception for both male and female subjects throughout the study and for at least 12 months after last study treatment administration if the risk of conception exists.
  • Recovery to baseline or =< grade 1 Common Terminology Criteria for Adverse Events (CTCAE) v5.0 from toxicities related to any prior treatments, unless AEs are clinically nonsignificant and/or stable on supportive therapy.
  • Able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines.

Exclusion Criteria:

  • Patients with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen of this trial.
  • Distant metastases. Regional lymphatic disease is acceptable.
  • Prior radiation therapy or definitive resection for pancreatic cancer.
  • Uncontrolled gastric or duodenal ulcer disease within 28 days of registration.
  • Chronic cough, defined 30% of days over 3 months with active symptoms at enrollment or over 12 months with last active symptoms occurring 6 months prior to enrollment.
  • Symptomatic hypotension (blood pressure < 90 systolic or < 60 diastolic at screening vital sign assessment) that has the potential to interfere with the patient's safety or ability to complete protocol treatment, at the discretion of the treating investigator.
  • Patients taking > 50mg losartan QD who, at the discretion of the treating investigator, cannot be reduced to the protocol defined regimen.
  • Patients taking an angiotensin II receptor blocker or an angiotensin-converting enzyme inhibitor who, at the discretion of the treating investigator, cannot be safely discontinued prior to Day 1 dosing.
  • Patients taking direct renin-angiotensin system inhibitors including aliskiren (Rasilez).
  • Prior allergy to an angiotensin II receptor blocker.
  • Concurrent use of direct renin inhibitor including aliskiren (Rasilez).

  • Patients with known history of:

    • Heart failure. Patients with heart failure, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better.
    • Patients with a prior history of treatment with cardiotoxic agents should be evaluated for heart failure prior to enrollment at the discretion of the treating investigator.
    • Solitary kidney, renal artery stenosis, or chronic renal failure.
  • Human immunodeficiency virus (HIV)-infected patients who are not on effective anti-retroviral therapy or have a detectable viral load within 6 months of trial entry.
  • Patients with known evidence of chronic hepatitis B virus (HBV) infection and a detectable HBV viral load
  • Patients with a history of hepatitis C virus (HCV) infection who have not been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.
  • Subject is currently enrolled on another investigational treatment study for pancreas cancer.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment (losartan, hypofractionated radiation therapy)
Beginning on day 1, patients receive losartan potassium PO QD. Beginning day 14, patients also undergo hypofractionated radiation therapy over 15 fractions 5 days a week for up to 3 weeks. Patients continue to receive losartan potassium PO QD during radiation therapy and for 28 days after completion of radiation therapy. Patients may begin additional anti-cancer therapy per investigator discretion after the last dose of HRT. Losartan can be given concurrently with additional therapy and Losartan dosing can continue until 28 days after last dose of HRT, regardless of when additional therapy is started.
Drug: Losartan Potassium
Given PO
Other Names:
  • Cozaar
  • losartan
Radiation: Hypofractionated Radiation Therapy
Undergo hypofractionated radiation therapy
Other Names:
  • Hypofractionated Radiotherapy
  • hypofractionation
Drug: Losartan
Given PO

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of dose-limiting toxicities (DLTs)
Time Frame: Up to 3 months (84 days) after completion of radiation therapy

A DLT is an event that occurred less than or equal to 84 days of finishing RT, has a possible causal relationship with lstudy treatment, and is one of the following:

  • Any grade ≥ 4 GI-related event; or

  • A grade ≥ 3

    • Gastric or duodenal ulcer;
    • Gastric, small bowel, or colonic hemorrhage from areas inside the hdPTV or pPTV;
    • Gastric or small bowel obstruction or stenosis located to areas inside the hdPTV or pPTV;
    • Gastrointestinal fistula in areas inside the hdPTV or pPTV;
    • Gastric, small bowel, or colonic fistula in areas inside the hdPTV or pPTV;
    • Vomiting, lasting > 1 week despite maximal medical interventions;
    • Abdominal pain or cramping, and lasting > 1 week despite maximal medical interventions;
    • Diarrhea, lasting > 1 week despite maximal medical interventions;
    • Weight loss;
    • Hepatic failure;

The proportion of subjects that experience this endpoint will be tabulated along with an exact 90% binomial confidence interval.
Up to 3 months (84 days) after completion of radiation therapy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Frequency of adverse events
Time Frame: Up to 3 months (84 days) after completion of radiation therapy
Will be graded according to Common Terminology Criteria for Adverse Events version (v) 5.0.
Up to 3 months (84 days) after completion of radiation therapy
Response rate (clinical and/or pathologic partial response [PR] and complete response [CR])
Time Frame: Up to 36 months post-treatment
Will be described using Response Evaluation Criteria in Solid Tumors v1.1. The proportion of subjects with a PR and CR will be reported along with exact binomial confidence intervals (Clopper-Pearson).
Up to 36 months post-treatment
Progressive free survival (PFS)
Time Frame: From the time of enrollment until disease progression or death (any cause), assessed up to 36 months post-treatment
Kaplan-Meier methods will be used to report PFS.
From the time of enrollment until disease progression or death (any cause), assessed up to 36 months post-treatment
Overall survival (OS)
Time Frame: From the patient?s first dose of study drug to death due to any cause, assessed up to 36 months post-treatment
Kaplan-Meier methods will be used to report OS.
From the patient?s first dose of study drug to death due to any cause, assessed up to 36 months post-treatment
Number patients that require a medical intervention or hospitalization due to hypotension
Time Frame: Up to 36 months post-treatment
Will be analyzed descriptively.
Up to 36 months post-treatment

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient reported quality of life assessment- review of symptoms and how they interfere in life
Time Frame: At study entry, during the final week of radiation therapy, and at each follow up visit
Will be assessed using MD Anderson Symptom Inventory-Gastrointestinal (MDASI-GI).
At study entry, during the final week of radiation therapy, and at each follow up visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Utah

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Shane Lloyd, Huntsman Cancer Institute/ University of Utah

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 8, 2019

Primary Completion (Actual)

December 6, 2024

Study Completion (Estimated)

August 8, 2026

Study Registration Dates

First Submitted

September 25, 2019

First Submitted That Met QC Criteria

September 25, 2019

First Posted (Actual)

September 27, 2019

Study Record Updates

Last Update Posted (Actual)

May 12, 2026

Last Update Submitted That Met QC Criteria

May 7, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HCI121104 (Other Identifier: Huntsman Cancer Institute/University of Utah)
  • NCI-2019-05882 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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