SBRT + Atezolizumab + Bevacizumab in Resectable HCC

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Massachusetts General Hospital
Study ID
NCT04857684
Phase
EARLY_PHASE1
Status
Active Not Recruiting

Conditions

Eligibility Criteria

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

Interventions

  • Atezolizumab — DRUG
    Intravenous Infusion
  • Bevacizumab — DRUG
    Intravenous Infusion
  • Stereotactic Beam Radiation Therapy (SBRT) — RADIATION
    External beam radiation

Study Details

This study is evaluating the safety and tolerability of neoadjuvant stereotactic body radiation therapy (SBRT) with atezolizumab and bevacizumab for treating resectable hepatocellular carcinoma. This study involves the following study interventions: * Atezolizumab * Bevacizumab * Stereotactic Beam Radiation Therapy (SBRT) * Surgery

Key Dates

Start date
Jun 18, 2021
Status verified
Sep 2025
Primary completion
Apr 29, 2026
Completion
Apr 29, 2027

Study Design

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

Arms

  • Experimental: Stereotactic beam radiation therapy (SBRT) +Atezolizumab + Bevacizumab
    Participants will: * undergo a pre-treatment biopsy with fiducial marker placement * receive Stereotactic beam radiation therapy (SBRT) on three treatment days which will be arranged on an every-other-day basis * receive two 3-week (21 days) cycles of atezolizumab plus bevacizumab * receive Atezolizumab on day 1 for 2 study cycles. * receive Bevacizumab 1x weekly for 2 study cycles * Surgery after SBRT and the two cycles of atezolizumab and bevacizumab, unless participants are otherwise informed by their doctor. The planned surgery will take place 6-8 weeks after the last infusions of atezolizumab and bevacizumab.

Primary Outcome Measure

Proportion of patients with grade 3-4 treatment-related adverse events as assessed by CTCAE v5.0 [ Time Frame: From enrollment to end of treatment, up to 6 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
Massachusetts General Hospital Cancer CenterBostonMassachusetts02114-

Find similar trials in Boston, MA

By condition
Liver cancer
By specialty
OncologyGI oncologyHepatology
By research site
Massachusetts General Hospital Cancer Center· Boston, MA

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