GLP-1 Receptor Agonist Plus SOC Treatment in First-line, Metastatic Pancreatic, Colorectal, or Hepatocellular Cancer
University of Arizona
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.
Description
The United States is facing a growing epidemic of obesity and type 2 diabetes, with over 42% of adults now classified as obese and nearly 20% of children affected by obesity. This rise has been driven by a combination of poor dietary habits, sedentary lifestyles, and social and economic factors that limit access to healthy food and healthcare. Type 2 diabetes, closely linked to obesity, affects more than 37 million Americans, with an additional 96 million adults estimated to have prediabetes. These conditions not only contribute to significant personal health burdens but also cost the U.S. eco…
Eligibility
- Age range
- 18–99 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Histological or cytological diagnosis of pancreatic adenocarcinoma or colorectal adenocarcinoma. Previous tumor tissue testing is acceptable. Please refer to the "additional HCC cohort criteria" below. * The subject has disease that is not amenable to curative-intent management (e.g., oligometastatic disease) * Measurable disease per RECIST v1.1 as determined by the investigator * Patients must be appropriate candidates for first-line, SOC treatment. * SOC treatment as defined by NCCN® guidelines or institutional standard is allowable, however, options restricted to:…
Interventions
- DrugGLP1-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.
Location
- University of Arizona Cancer CenterTucson, Arizona