Evaluating the Impact of GLP-1 Receptor Agonists With Total Neoadjuvant Therapy in Rectal Cancer (NCT07314528) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Evaluating the Impact of GLP-1 Receptor Agonists With Total Neoadjuvant Therapy in Rectal Cancer
42 participantsStarted 2026-04
Plain-language summary
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
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Weight Loss
Timeframe: 6 months
2
Metabolic Profile of the Tissue
Timeframe: From enrolment to operation within 1 year
3
Inflammatory Mediators
Timeframe: From enrolment to surgical resection within 1 year
4
GLP-1 effects on mitochondrial fitness
Timeframe: From enrolment to surgical resection within 1 year
5
Mapping systemic inflammatory profiles
Timeframe: From enrolment to surgical resection within 1 year
6
Mapping circulating immune systems
Timeframe: From enrolment to surgical resection within 1 year
7
Mapping tumour resident immune system
Timeframe: From enrolment to surgical resection within 1 year