Brachytherapy Followed by Nivolumab Prior to Surgery in Rectal Cancer
ConditionLocally Advanced Rectal Cancer
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorDr. Te Vuong
About this trial
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.
Eligibility criteria
Qualifiers
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.
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);
Disqualifiers
Prior anticancer therapy for rectal cancer.
Contraindication to safe MRI imaging.
Evidence of bowel obstruction on MRI or clinical evaluation.
Evidence of distant metastasis.
Trial design
Treatments tested in this trial
- Nivolumab
- HDRBET
- Total Mesorectal Excision (TME)
Treatment groups
10 Participants
are divided into 1 treatment groupSponsors and collaborators
Dr. Te Vuong
Lead sponsor
Sir Mortimer B. Davis - Jewish General Hospital
Sponsor institution
Source ClinicalTrials.gov