Brachytherapy Followed by Nivolumab Prior to Surgery in Rectal Cancer

Sponsor
Dr. Te Vuong
Study ID
NCT07645118
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Locally Advanced Rectal Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Nivolumab — DRUG
    2 doses of nivolumab 3 mg/kg mg IV every 2 weeks
  • HDRBET — DEVICE
    26 Gy in 4 fractions Administered over Days 1-4 as per institutional standard
  • Total Mesorectal Excision (TME) — PROCEDURE
    Targeted to take place 6-8 weeks post completion of HDREBT (maximum 12 weeks)

Study Details

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.

Key Dates

First listed
Jun 12, 2026
Start date
Jul 31, 2026
Status verified
Jun 2026
Primary completion
Dec 31, 2028
Completion
Dec 31, 2030

Study Design

Enrollment
10 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Brachytherapy (HDREBT) followed by nivolumab and total mesorectal excision
    HDREBT (26 Gy delivered in 4 fractions over Days 1-4) followed by up to 2 doses of nivolumab (3 mg/kg mg IV every 2 weeks starting at 7-14 days post HDREBT). Surgical resection of tumor (6-8 weeks post HDREBT)

Primary Outcome Measure

Pathologic complete response (pCR) [ Time Frame: This is assessed at the time of total mesorectal excision surgery, occurring approximately 12 weeks after enrollment. ]

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