OncoMatch/Clinical Trials/NCT06545526
Chemopreventive Effect of Combination of Celecoxib and Metformin in Patients With Familial Adenomatous Polyposis
Is NCT06545526 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments including celecoxib monotherapy and celecoxib and metformin combination for familial adenomatous polyposis.
Treatment: celecoxib monotherapy · celecoxib and metformin combination — Familial adenomatous polyposis (FAP) leads to adenomas and eventual adenocarcinomas in colon and less frequently, duodenum. Chemopreventive strategies have been studied in FAP patients to delay the development of adenomas and cancers. The non-steroidal anti-inflammatory drugs (NSAIDs) and selective cyclooxygenase-2 inhibitor have shown the regression of colorectal and duodenal adenomas in FAP patients. However, these drugs showed gastrointestinal damage and cardiovascular risks, and new preventive strategies are needed. Metformin, an anti-diabetic drug, has recently been suggested to have a suppressive effect on tumorigenesis via inhibition of mTOR pathway, and have an inhibitory effect on polyp recurrence after removal of sporadic colorectal polyps. In addition, metformin has a number of potential mechnisms of carciovascular bebefit. We devised a randomized, open-label, comparative study to evaluate the effect of combination of celecoxib and metformin on polyps of colorectum and duodenum in FAP patients.
Check if I qualifyExtracted eligibility criteria
Prior therapy
Cannot have received: colectomy
Exception: colectomy within previous 12 months or need to undergo colectomy within 8 months after randomization
FAP patients who had a history of colectomy within the previous 12 months or need to undergo colectomy within 8 months after randomization
Cannot have received: NSAIDs or aspirin
Exception: use three or more times a week within 3 months of randomization
FAP patients who used NSAIDs (non-steroidal anti-inflammatory drugs) or aspirin three or more times a week within 3 months of randomization
Lab requirements
Kidney function
abnormal results of renal function test excluded
Liver function
abnormal results of liver function test excluded
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify