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Brachytherapy Followed by Nivolumab Prior to Surgery in Rectal Cancer

NCT07645118 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2026-06-12

No results posted yet for this study

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.

Conditions

  • Locally Advanced Rectal Cancer

Interventions

DRUG

Nivolumab

2 doses of nivolumab 3 mg/kg mg IV every 2 weeks

DEVICE

HDRBET

26 Gy in 4 fractions Administered over Days 1-4 as per institutional standard

PROCEDURE

Total Mesorectal Excision (TME)

Targeted to take place 6-8 weeks post completion of HDREBT (maximum 12 weeks)

Sponsors & Collaborators

  • Dr. Te Vuong

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-31
Primary Completion
2028-12-31
Completion
2030-12-31

Countries

  • Canada

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07645118 on ClinicalTrials.gov