GLP-1 RA Plus SOC Treatment in First-line, Metastatic Pancreatic, Colorectal, or Hepatocellular Cancer
NCT07627191 · Status: NOT_YET_RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 30
Last updated 2026-07-02
Summary
There is a growing number of patients diagnosed with gastrointestinal cancers who are also simultaneously being treated with GLP-1 Receptor Agonists (RA)s. To date, no clinical trial data exists to establish safety and/or feasibility with use of GLP-1 RAs during chemotherapy in the metastatic setting. The goal of this clinical trial is to evaluate the safety, tolerability, preliminary efficacy, and correlative analyses of combining GLP-1 RAs with standard chemotherapy in patients with metastatic pancreatic, colorectal, or hepatocellular cancers in the first-line setting.
Conditions
Interventions
- DRUG
-
GLP1-RA (semaglutide)
Patients will receive 6 months of weekly semaglutide; weekly subcutaneous injection; dose escalation will occur every 4 weeks with dose titration as follows: 0.25 mg → 0.5 mg → 1 mg → 1.7 mg → Maintenance at 2.4 mg or 1.7 mg pending tolerability.
Sponsors & Collaborators
-
University of Arizona
lead OTHER
Principal Investigators
-
Aaron J Scott, MD · University of Arizona
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 99 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-07-10
- Primary Completion
- 2028-06-30
- Completion
- 2028-06-30
- FDA Drug
- Yes
Countries
- United States
Study Locations
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