Atezolizumab+Bevacizumab+SBRT in Unresectable HCC

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Massachusetts General Hospital
Study ID
NCT05096715
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

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

Interventions

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

Study Details

This research study is evaluating the safety and tolerability of the drugs atezolizumab and bevacizumab with stereotactic body radiation therapy (SBRT) for treating unresectable hepatocellular carcinoma. This study involves the following interventions: * Atezolizumab * Bevacizumab * Stereotactic body radiation therapy (SBRT)

Key Dates

Start date
Aug 23, 2022
Status verified
Feb 2026
Primary completion
Jan 31, 2027
Completion
Jan 31, 2032

Study Design

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

Arms

  • Experimental: Stereotactic beam radiation therapy (SBRT) +Atezolizumab + Bevacizumab
    Study will begin with a safety lead of 6 participants to determine the maximum tolerated dose (MTD) of Stereotactic beam radiation therapy (SBRT) with atezolizumab and bevacizumab followed by study expansion to 14 more participants after maximum tolerated dose (MTD) is established. Safety Lead-In: 6 cycles/18 weeks (study cycle is 3 weeks/21 days) * Cycle 1: Atezolizumab + Bevacizumab (1x) with Stereotactic beam radiation therapy (SBRT) every 1-3 days * Cycles 2-6: Atezolizumab + Bevacizumab (1x) every 3 weeks Expanded Study: * Cycle 1: Atezolizumab + Bevacizumab (1x) with Stereotactic beam radiation therapy (SBRT) every 1-3 days * Cycles 2-End:Atezolizumab + Bevacizumab (1x) every cycle

Primary Outcome Measure

Dose Limiting Toxicity Rate [ Time Frame: 18 weeks ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Beth Israel Deaconess Medical CenterBostonMassachusetts02215
Matthew Abrams, MD
[email protected]
617-667-2345
Matthew Abrams, MD (PRINCIPAL_INVESTIGATOR)
Dana-Farber Cancer InstituteBostonMassachusetts02215
Harvey Mamon, MD, PhD
[email protected]
(617) 732-8821
Harvey Mamon, MD, PhD (PRINCIPAL_INVESTIGATOR)
Massachusetts General Hospital Cancer CenterBostonMassachusetts02114
Jennifer Y Wo, MD
[email protected]
(617) 726-6050
Jennifer Y Wo, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Boston, MA

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By specialty
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By research site
Beth Israel Deaconess Medical Center· Boston, MADana-Farber Cancer Institute· Boston, MAMassachusetts General Hospital Cancer Center· Boston, MA

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