Recruiting nowPhase 2
What this trial is trying to do
The researchers are testing whether high-dose-rate endorectal brachytherapy (HDRBET), which delivers targeted radiation inside the rectum, followed by two doses of nivolumab, an immunotherapy drug that helps immune cells recognise cancer, can make the tumour disappear under the microscope before surgery. The treatment sequence is given before total mesorectal excision, an operation to remove the rectal cancer.
The idea is that combining local radiation with immunotherapy could produce more tumour killing before surgery. The trial is measuring safety, practicality and pathologic complete response—no cancer found in the tissue removed at surgery—rather than whether patients live longer or avoid surgery.
Worth knowing: This is a very small, non-randomised Phase 2 study of 10 people, so it has no comparison group and cannot establish whether the approach is better than standard treatment.
Written from the trial's own registry entry to explain what the researchers are testing and why. Nothing here is a result — this trial has not reported one — and it is not a view on whether the treatment works or on whether it would suit you.
| Registry number | NCT07645118 |
|---|---|
| Recruitment | Recruiting now |
| Phase | Phase 2 |
| Design | open label |
| Taking part | 10 people (planned) |
| Who can join | aged 18 Years and over |
| Run by | Dr. Te Vuong |
| Started | |
| Main results expected | |
| Record last updated |
What is being tested
- Drug Nivolumab
- Device HDRBET
- Procedure Total Mesorectal Excision (TME)
What it is measuring
Pathologic complete response (pCR)
This is the trial's main question — the one it is designed and sized to answer. Anything else it reports is a secondary finding, and secondary findings are far more likely to be chance.
Phase 2. Tests whether the treatment works well enough to be worth a larger trial. Usually too small to prove it changes survival.
How the researchers describe it
This is a small Phase II study testing whether targeted internal radiation treatment (HDREBT) followed by two doses of the immunotherapy drug Nivolumab is safe, practical, and potentially effective before patients undergo surgery (TME) to remove rectal cancer.
Written by the trial’s sponsor, quoted from its ClinicalTrials.gov record.
What this trial is looking for
- Any genotype
- Locally advanced
Read automatically from the criteria below, to make the list searchable. It is a summary of what the text mentions, not a decision about whether you qualify — and where the two disagree, the criteria are right and this is wrong.
Who the trial is looking for
Inclusion Criteria
1. Age ≥18 years at the time of consent.
2. Histologically confirmed rectal adenocarcinoma arising within 5 to 15 cm of the anal verge as measured by sigmoidoscopy or MRI.
3. Rectal cancer staging:
1. Clinical Stage cT2 or cT3 based on high resolution pelvic MRI;
2. No evidence of distant metastases (cM0) on contrast -enhanced CT of chest, abdomen and pelvis (or PET/CT if clinically indicated);
3. Disease deemed technically resectable with curative intent by multidisciplinary tumor board (MDT)*. No radiologic evidence of unresectable local disease (e.g., tumor fixation or invasion of adjacent unresectable structures).
4. At least one of the following adverse prognostic features observed on baseline MRI:
1. Node-positive disease (cN+);
2. Threatened mesorectal fascia (MRF) defined as distance from tumor to mesorectal fascia < 1mm on pelvic MRI;
3. Extramural venous invasion (EMVI+).
5. Proficient mismatch repair (pMMR) status, as determined by immunohistochemistry and/or microsatellite instability-low (MSI-L) status by next-generation sequencing
6. Planned management includes neoadjuvant therapy with radiotherapy followed by curative-intent TME.
7. Prior external beam pelvic radiation for other malignancy (prostate, gynecology, lymphoma, bladder) are acceptable, provided the colorectal surgeon deems the patient as a candidate for TME surgery.
8.
This is an extract. Whether you qualify is decided by the trial team against the full criteria, not by reading this page. Read the full eligibility criteria
Where it is running
Running at 1 site. Listed in: Canada.
Individual hospitals, and whether each is currently open, are listed on the registry record. Sites open and close throughout a trial.
Worth asking your oncology team
Being listed here is not a recommendation, and no one page can tell you whether a trial is right for you. These are the questions it raises.
- Is this trial open at a hospital I could realistically travel to?
- Given my stage, my previous treatment and my tumour's molecular profile, would I be eligible?
- What would I be giving up by joining — is the comparison arm the treatment I would otherwise be having?
- What is already known about the safety of what is being tested?
The source
Registry record NCT07645118, registered by Dr. Te Vuong on ClinicalTrials.gov, a public database run by the US National Library of Medicine. The details on this page come from that record and are only ever as current as the sponsor has kept it.
This is a listing of a registered clinical trial, reproduced for information. It is not a recommendation, this site has no connection to the trial or its sponsor, and being listed here says nothing about whether the treatment works. Talk to your own oncology team before pursuing any trial.
This article summarises published research for general information. It is not medical advice, and it is not a substitute for a conversation with your own oncology team, who know your case. Do not start, stop, or change any treatment or supplement on the basis of what you read here.