GLP-1 RA for Colorectal Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine whether semaglutide, a GLP-1 Receptor Agonist, can be safely combined with standard chemotherapy to treat certain advanced cancers, such as metastatic colorectal cancer. Researchers seek to discover if adding semaglutide enhances the effectiveness of standard cancer treatments while maintaining patient safety. The trial targets individuals with specific types of advanced cancers who have a body mass index (BMI) over 25 and are undergoing their first set of cancer treatments. As an Early Phase 1 trial, this research focuses on understanding the treatment's effects in people, offering participants a chance to contribute to groundbreaking cancer treatment development.
Do I need to stop my current medications for the trial?
The trial information does not specify if you need to stop taking your current medications. However, it does mention that patients on insulin are excluded, and those with HBV must be on antiviral therapy. It's best to discuss your specific medications with the trial team.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that semaglutide, a type of medication, is generally safe for use. Large studies involving over 60,000 participants found no increased risk of colorectal cancer compared to a placebo. In fact, these medications may lower the risk of developing colorectal cancer. Some studies report a significant decrease in colon cancer risk with these drugs. Additionally, the FDA has not identified any safety concerns related to colorectal cancer with this type of medication. Overall, these findings suggest semaglutide is well-tolerated, but this trial is needed to confirm its safety when used with chemotherapy for certain cancers.12345
Why are researchers excited about this trial's treatments?
Researchers are excited about using Semaglutide, a GLP-1 receptor agonist, for treating colorectal cancer because it offers a unique approach compared to the standard treatments like FOLFOX or FOLFIRI. Unlike traditional chemotherapy, which directly targets cancer cells, Semaglutide works by mimicking a hormone that regulates insulin, potentially influencing cancer growth indirectly by affecting metabolism and weight. This novel mechanism provides a fresh angle in tackling cancer, particularly for patients with a higher BMI, and could complement existing therapies to improve outcomes.
What evidence suggests that this trial's treatments could be effective for metastatic colorectal cancer?
Research has shown that medications like semaglutide, known as GLP-1 receptor agonists, may help reduce the risk and slow the progression of certain cancers, such as colorectal, pancreatic, and liver cancer. In this trial, participants with metastatic colorectal adenocarcinoma will receive semaglutide alongside standard-of-care (SOC) treatment, which may include FOLFOX or FOLFIRI with or without bevacizumab. For pancreatic cancer, participants will receive semaglutide with SOC treatment, specifically modified FOLFIRINOX. In liver cancer, semaglutide will be administered with SOC treatment, specifically Tremelimumab/Durvalumab. This evidence suggests that semaglutide might effectively manage these cancers along with standard treatments.25678
Who Is on the Research Team?
Aaron J Scott, MD
Principal Investigator
University of Arizona
Are You a Good Fit for This Trial?
This trial is for adults with newly diagnosed, metastatic pancreatic, colorectal, or liver cancer who have not yet received treatment for their advanced disease. Participants must be able to safely receive both chemotherapy and the study drug.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive GLP-1 RA weekly in combination with standard of care chemotherapy for up to 6 months or until disease progression
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Semaglutide
Trial Overview
The study is testing whether adding a medication called semaglutide (a GLP-1 receptor agonist) to standard first-line chemotherapy is safe and effective in people with advanced gastrointestinal cancers.
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
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.
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.
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Arizona
Lead Sponsor
Citations
GLP-1 receptor agonists and cancer: current clinical evidence ...
In a meta-analysis of five studies that included over 2 million people, colorectal cancer risk was significantly lower in people using GLP-1R ...
2.
onclive.com
onclive.com/view/emerging-evidence-positions-glp-1-receptor-agonists-as-a-novel-strategy-to-reduce-crc-riskEmerging Evidence Positions GLP-1 Receptor Agonists as ...
GLP-1 RA use has also been associated with 62% lower odds of 5-year mortality in patients with established colon cancer (OR, 0.38; 95% CI, 0.21- ...
Real-world analysis on the impact of GLP-1 receptor ...
Conclusions: GLP-1RA therapy was associated with reduced all-cause mortality in patients with CRC, without an observed increase in metastatic ...
Glucagon-like Peptide-1 Receptor Agonists and Colorectal ...
Using 1:1 propensity matching, the study found GLP-1RA therapy was associated with a significantly reduced risk of CRC in patients with T2DM relative to insulin ...
5.
oncnursingnews.com
oncnursingnews.com/view/real-world-data-favor-glp-1-vs-aspirin-in-colorectal-cancer-preventionReal-World Data Favor GLP-1 vs Aspirin in Colorectal ...
At a median 6-year follow-up for GLP-1RA users and 5 years for aspirin users, the use of a GLP-1RA reduced the risk of CRC by 35.7% compared ...
Association between GLP-1 receptor agonists as a class and ...
Overall, this study suggests a significantly increased risk of colorectal cancer associated with GLP-1 RA use in patients receiving GLP-1 RAs.
7.
endocrinologyadvisor.com
endocrinologyadvisor.com/news/glp1-ra-therapy-colon-cancer-risk-reduction/GLP-1 RAs Linked to Reduced Colon Cancer Risk
In analyses of specific drugs, a significantly lower risk for colon cancer was observed with use of albiglutide (RR, 0.33; 95% CI, 0.12-0.97) ...
GLP-1 receptor agonist vs aspirin for primary prevention of ...
Conclusions: In this real-world comparison, GLP-1RAs were associated with a 26% relative reduction in CRC incidence compared to aspirin. These ...
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.