← Back to Search

Losartan + Radiation Therapy for Pancreatic Cancer (SHAPER Trial)

Phase 1
Recruiting
Led By Shane Lloyd
Research Sponsored by University of Utah
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Must not have
Patients with known evidence of chronic hepatitis B virus (HBV) infection and a detectable HBV viral load
Patients taking direct renin-angiotensin system inhibitors including aliskiren (Rasilez)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 36 months post-treatment
Awards & highlights
No Placebo-Only Group

Summary

This trial is studying losartan and hypofractionated radiation therapy to see if they are effective in treating pancreatic cancer.

Who is the study for?
This trial is for patients with pancreatic cancer that's borderline resectable or locally advanced and unresectable. They must have had at least one round of specific chemotherapy, be within certain blood and organ function parameters, not pregnant, willing to use effective contraception, and able to consent. Exclusions include those on high-dose losartan, other trials, prior malignancies affecting safety assessments, previous radiation or surgery for pancreatic cancer, uncontrolled ulcers or chronic coughs among others.
What is being tested?
The SHAPER trial is testing the combination of losartan (a drug that may improve blood flow) with hypofractionated radiation therapy (which delivers higher doses in a shorter period), following chemotherapy. The goal is to see if this combo is more effective than just radiation alone in treating pancreatic cancer by killing more tumor cells with fewer side effects.
What are the potential side effects?
Potential side effects from losartan might include low blood pressure symptoms like dizziness or fainting. Radiation therapy can cause skin irritation at the treatment site, fatigue, nausea and potential damage to nearby organs depending on its location.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My cancer is confirmed as pancreatic ductal adenocarcinoma.
Select...
My pancreas cancer is advanced but hasn't been removed.
Select...
I have tried FOLFIRINOX or gemcitabine chemotherapy.
Select...
I am fully active and can carry on all pre-disease activities without restriction.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have chronic hepatitis B with a detectable virus level.
Select...
I am currently taking medication for my blood pressure that includes aliskiren.
Select...
I have had radiation or surgery for pancreatic cancer.
Select...
I have a single kidney, narrowed kidney arteries, or ongoing kidney failure.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 36 months post-treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 36 months post-treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Grade 3 or higher gastrointestinal toxicity rate
Secondary study objectives
Frequency of adverse events
Number patients that require a medical intervention or hospitalization due to hypotension
Overall survival (OS)
+2 more
Other study objectives
Patient reported quality of life assessment- review of symptoms and how they interfere in life

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (losartan, hypofractionated radiation therapy)Experimental Treatment5 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Hypofractionated Radiation Therapy
2016
Completed Phase 3
~130
Losartan
2003
Completed Phase 4
~3000
Losartan Potassium
2007
Completed Phase 4
~1060

Find a Location

Who is running the clinical trial?

University of UtahLead Sponsor
1,143 Previous Clinical Trials
1,697,109 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,937 Previous Clinical Trials
41,022,354 Total Patients Enrolled
Shane LloydPrincipal InvestigatorHuntsman Cancer Institute/ University of Utah

Media Library

Hypofractionated Radiation Therapy Clinical Trial Eligibility Overview. Trial Name: NCT04106856 — Phase 1
Pancreatic Cancer Research Study Groups: Treatment (losartan, hypofractionated radiation therapy)
Pancreatic Cancer Clinical Trial 2023: Hypofractionated Radiation Therapy Highlights & Side Effects. Trial Name: NCT04106856 — Phase 1
Hypofractionated Radiation Therapy 2023 Treatment Timeline for Medical Study. Trial Name: NCT04106856 — Phase 1
~3 spots leftby Aug 2025