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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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • 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/Surgery

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

Treatment groups

10 Participants
are divided into 1 treatment group
Group A: Brachytherapy (HDREBT) followed by nivolumab and total mesorectal excisionExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Pathologic complete response (pCR)

Time frame
This is assessed at the time of total mesorectal excision surgery, occurring approximately 12 weeks after enrollment.

Secondary outcomes

1

Incidence and severity of adverse events, as per CTCAE criteria v6.0

Time frame
From time of first treatment through 90 days following last treatment with nivolumab
2

Assess feasibility of treatment sequence

Completion of treatment of all treatment modalities within protocol-defined timeframes (brachytherapy, immunotherapy and surgery)

Time frame
This is assessed from the time of enrollment until the time of surgery, approximately 12 weeks after enrolment.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Dr. Te Vuong

Lead sponsor

Sir Mortimer B. Davis - Jewish General Hospital

Sponsor institution

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: