Evaluating the Impact of GLP-1 Receptor Agonists With Total Neoadjuvant Therapy in Rectal Cancer
- Status
- Not yet recruitingResults none
- Why it is watched
- non-weight indication: inflammation, immune, cancer
- Who it enrolls
- age 18 Years to no upper limit; BMI ≥25 required; conditions: Rectal Cancer Patients; Obesity &Amp; Overweight; Locally Advanced Rectal Cancer (LARC); Total Neoadjuvant Therapy
- Interventions
- GLP-1 receptor agonist; Total neoadjuvant therapy (TNT)
- Conditions
- Rectal Cancer Patients; Obesity &Amp; Overweight; Locally Advanced Rectal Cancer (LARC); Total Neoadjuvant Therapy; GLP-1
- Phase and size
- Phase 2 · 42 participants
- Dates
- Start 2026-04
Primary completion 2028-09 - Sponsor
- St. James's Hospital, Ireland (Other)
- Last checked
- Sep 13, 2026
01Endpoints
What the trial will measure
- Weight Loss6 months
- Metabolic Profile of the TissueFrom enrolment to operation within 1 year
- Inflammatory MediatorsFrom enrolment to surgical resection within 1 year
- GLP-1 effects on mitochondrial fitnessFrom enrolment to surgical resection within 1 year
- Mapping systemic inflammatory profilesFrom enrolment to surgical resection within 1 year
- Mapping circulating immune systemsFrom enrolment to surgical resection within 1 year
- Mapping tumour resident immune systemFrom enrolment to surgical resection within 1 year
02Eligibility
Who can take part
Inclusion Criteria: * Written informed consent according to local guidelines obtained prior to any study-related activities. * Histologically confirmed mismatch repair protein proficient adenocarcinoma of the rectum. * BMI ≥25 kg/m² * Radiological confirmed \>T2, Node positive, Threatened Surgical Margin and/or EMVI+ by MRI * Imaging available for radiomics analysis * Absence of metastatic disease at registration. * Adequate renal function is defined as calculated creatinine clearance (CrCl) \>50ml/min. * ANC \> 1.5 cells/mm3, HGB \> 8.0 gm/dl, PLT \> 150,000/mm3, total bilirubin ≤ 1.5 x ULN (except in patients with Gilbert's Syndrome who must have total bilirubin ≤ 3.0 x ULN), AST≤ 3 x ULN, ALT ≤ 3 x ULN * Able to tolerate medication. * ECOG 0-2 Exclusion Criteria: * Received prior chemotherapy or radiotherapy * Previous or concurrent active malignancy ≤ 5 years prior to registration, with the exception of non-melanotic skin cancer or carcinoma in situ of any type, or other cancers that the treating investigator does not feel will impact the study objectives. * Locally advanced disease T3N+ or T4 disease. * Recurrent rectal cancer * Metastatic disease at presentation * Patients unable to undergo MRI * Patients having already received weight-loss intervention (pharmacological or surgical)
03Change log
Registry changes
No changes recorded since the trial was added.