GLP-1 RA Plus SOC Treatment in First-line, Metastatic Pancreatic, Colorectal, or Hepatocellular Cancer

Part of paid clinical trials in Tucson, Arizona.

Sponsor
University of Arizona
Study ID
NCT07627191
Phase
EARLY_PHASE1
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

  • GLP1-RA (semaglutide) — DRUG
    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.

Study Details

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.

Key Dates

Start date
Jun 30, 2026
Status verified
Jun 2026
Primary completion
Jun 30, 2028
Completion
Jun 30, 2028

Study Design

Enrollment
30 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Metastatic Pancreatic Adenocarcinoma (PDAC)
    30 patients with a diagnosis of 1st line metastatic or unresectable PDAC, CRC, or HCC and a BMI \>25 will receive GLP1 RA weekly + SOC treatment for 6 months or disease progression whichever comes first. SOC treatment for pancreatic cancer is modified FOLFIRINOX.
  • Experimental: Metastatic Colorectal Adenocarcinoma (CRC)
    10 patients with a diagnosis of 1st line metastatic or unresectable CRC and a BMI \>25 will receive GLP1 RA weekly + SOC treatment for 6 months or disease progression whichever comes first. SOC treatment for CRC is FOLFOX or FOLFIRI +/- bevacizumab.
  • Experimental: Metastatic Hepatocellular Carcinoma (HCC)
    10 patients with a diagnosis of 1st line metastatic or unresectable HCC and a BMI \>25 will receive GLP1 RA weekly + SOC treatment for 6 months or disease progression whichever comes first. SOC treatment for HCC is Tremelimumab/Durvalumab.

Primary Outcome Measure

Incidence of Treatment Emergent Adverse Events [Safety] attributed to GLP1-RA and/or its interaction with chemotherapy [ Time Frame: Up to 6 months or at time of disease progression, whichever comes first ]

Central Contacts

Locations (1)

FacilityCityStateZIP
University of Arizona Cancer CenterTucsonArizona85724

Find similar trials in Tucson, AZ

By condition
Colorectal cancerLiver cancerPancreatic cancer
By specialty
OncologyGI oncologyHepatology
By research site
University of Arizona Cancer Center· Tucson, AZ

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