Brachytherapy Followed by Nivolumab Prior to Surgery in Rectal Cancer (NCT07645118) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Brachytherapy Followed by Nivolumab Prior to Surgery in Rectal Cancer
Canada10 participantsStarted 2026-07
Plain-language summary
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.
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
. Age ≥18 years at the time of consent.
. Histologically confirmed rectal adenocarcinoma arising within 5 to 15 cm of the anal verge as measured by sigmoidoscopy or MRI.
. Rectal cancer staging:
. Clinical Stage cT2 or cT3 based on high resolution pelvic MRI;
. No evidence of distant metastases (cM0) on contrast -enhanced CT of chest, abdomen and pelvis (or PET/CT if clinically indicated);
. 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).
. At least one of the following adverse prognostic features observed on baseline MRI:
. Node-positive disease (cN+);
Exclusion criteria
. Prior anticancer therapy for rectal cancer.
. Contraindication to safe MRI imaging.
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
Pathologic complete response (pCR)
Timeframe: This is assessed at the time of total mesorectal excision surgery, occurring approximately 12 weeks after enrollment.
. Evidence of bowel obstruction on MRI or clinical evaluation.
. Evidence of distant metastasis.
. Medical or surgical contraindications to major pelvic surgery
. Active autoimmune disease requiring systemic immunosuppressive therapy.
. Active/uncontrolled infection. Infectious screening for HIV, Hepatitis B (HBV), Hepatitis C (HBC) and tuberculosis will be performed at screening:
. Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received HBV anti-viral therapy for at least 4 weeks; and have undetectable HBV viral load prior to starting treatment. Participants should remain on anti-viral therapy throughout study intervention and follow local guidelines for HBV anti-viral therapy post completion of study intervention.