Study of Atezolizumab and Bevacizumab With Y-90 TARE in Patients With Unresectable Hepatocellular Carcinoma (HCC)

Part of paid clinical trials in Washington D.C., District of Columbia.

Sponsor
Aiwu Ruth He, MD
Study ID
NCT04541173
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

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

Interventions

  • Y-90 TARE — OTHER
    This plan will involve treating the predominant liver lesions with segment Y-90 TARE using predetermined dosimetry, while keeping FLR equal or greater than 40% (FLR is estimated by excluding the liver volume of Y-90 infused distribution). The maximal amount of Y-90 TARE treatment will be limited to only one lobe of the liver if segmental Y-90 TARE is not possible to treat the predominant lesion. Since segmental Y-90 TARE may result in less long term liver damage compared to lobal Y-90 TARE, segmental Y-90 TARE treatment is preferred to lobar Y-90 TARE if segmental Y-90 TARE treatment is able to treat all blood supply to the predominant lesion or lesion with vascular invasion to preserve liver function. For segmental treatment, a minimum tumor dose of 190 Gy should be used for glass microspheres and 120 Gy for resin microspheres. For lobar treatment, a minimum dose of 100 Gy should be used for resin microspheres.
  • Atezolizumab — DRUG
    Atezolizumab 1200 mg will be delivered as an IV infusion on Day 1 of each cycle (every 3 weeks). The initial dose will be delivered over 60 (± 15) minutes and if tolerated subsequent infusions may be given over 30 minutes.
  • Bevacizumab — DRUG
    Bevacizumab 15 mg/kg will be delivered as an IV infusion on Day 1 of each 3 week cycle.The initial dose will be delivered over 90 minutes (±15 minutes) and if tolerated subsequent infusions may be given over 60 minutes

Study Details

This is an open-label, multi-center, randomized phase II study comparing the Y90 TARE followed by bevacizumab and atezolizumab treatment to the Y90 TARE treatment alone in unresectable advanced stage HCC.

Key Dates

Start date
Nov 30, 2020
Status verified
Jun 2024
Primary completion
Jun 18, 2023
Completion
Jun 30, 2023

Study Design

Enrollment
6 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Arm A
    TARE alone
  • Experimental: Arm B
    TARE then Bevacizumab and Atezolizumab

Primary Outcome Measure

Progression Free Survival (PFS) by RECIST 1.1 [ Time Frame: Up to a maximum of 16 months. ]

Locations (6)

FacilityCityStateZIPSite coordinators
Georgetown UniversityWashington D.C.District of Columbia20057-
Moffitt Cancer CenterTampaFlorida33612-
University of MarylandBaltimoreMaryland21201-
Boston Medical CenterBostonMassachusetts02118-
Roswell Park Cancer InstituteBuffaloNew York14263-
Vanderbilt-Ingram Cancer CenterNashvilleTennessee37232-

Find similar trials in Washington D.C., DC

By condition
Liver cancer
By specialty
OncologyGI oncologyHepatology
By research site
Georgetown University· Washington D.C., DCMoffitt Cancer Center· Tampa, FLUniversity of Maryland· Baltimore, MDBoston Medical Center· Boston, MARoswell Park Cancer Institute· Buffalo, NYVanderbilt-Ingram Cancer Center· Nashville, TN

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