NCT07314528Not yet recruitingPhase 2
Evaluating the Impact of GLP-1 Receptor Agonists With Total Neoadjuvant Therapy in Rectal Cancer
A Phase II Multi-institutional Randomized Trial Evaluating the Impact of GLP-1 Receptor Agonists in Combination With Total Neoadjuvant Therapy for Locally Advanced Rectal Cancer
Source: ClinicalTrials.gov · Last updated 2 Jan 2026
Brief summary (registry, in English)
The goal of this clinical trial is to see if adding a weight loss medication (GLP-1 receptor drug) to patients with an increased BMI receiving treatment for rectal cancer prior to surgery (total neoadjuvant chemoradiotherapy) improves cancer outcomes. The main questions it aims to answer is 1. Does the drug increase weight loss in rectal cancer patients with a high BMI 2. Does the drug improve response rates to chemotherapy and radiotherapy 3. Does the drug improve survival outcomes and if cancer returns Researchers will compare this drug in one group against a group of patients receiving preoperative total neoadjuvant chemoradiotherapy without the drug Patients will be required to 1\) take the GLP-1 receptor agonist drug during TNT or just having TNT alone as per standard hospital protocols Body weight will be measured at three predefined time points: 1. Baseline: Prior to initiation of semaglutide or TNT 2. Pre-TNT: Start of TNT (for the intervention arm, this is 4 weeks after semaglutide initiation) 3. Post-TNT: Within 7 days following completion of TNT and prior to definitive surgery Patients will complete their treatment and go on to have surgery as per standard methods for treating rectal cancer
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 42 (estimated)
- First submitted
- 28 Aug 2025
- Start date
- Apr 2026
- Primary completion date
- Sept 2028
- Lead sponsor
- St. James's Hospital, Ireland
- Diseases
- Obesity
- NCT number
- NCT07314528
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 42
- From Apr 2026 to the primary completion date, Sept 2028
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
- Patients having already received weight-loss intervention (pharmacological or surgical)
Other illness
- Locally advanced disease T3N+ or T4 disease.
- Recurrent rectal cancer
- Metastatic disease at presentation
Other
- Patients unable to undergo MRI
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.