Atezolizumab and Bevacizumab Pre-Liver Transplantation for Patients With Hepatocellular Carcinoma Beyond Milan Criteria

Part of paid clinical trials in Houston, Texas.

Sponsor
The Methodist Hospital Research Institute
Study ID
NCT05185505
Phase
PHASE4
Status
Recruiting
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Conditions

Eligibility Criteria

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

Interventions

  • Atezolizumab — DRUG
    1200 mg administered every three weeks for up to 6 months (up to 8 cycles) during the liver transplant waiting period
  • Bevacizumab — DRUG
    15 mg/kg administered every three weeks for up to 6 months (up to 8 cycles) during the liver transplant waiting period

Study Details

Patients with hepatocellular carcinoma (HCC) beyond Milan Criteria (MC) who are transplant-eligible will be treated with 6 months of neoadjuvant/downstaging atezolizumab plus bevacizumab while receiving standard of care transarterial chemoembolization (TACE). We hypothesize that atezolizumab and bevacizumab can appropriately bridge patients with HCC beyond MC to transplantation and not increase the risk of 1-year post-transplant rejection.

Key Dates

Start date
Jan 30, 2023
Status verified
Jan 2023
Primary completion
Apr 30, 2027
Completion
Oct 31, 2027

Study Design

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

Arms

  • Experimental: Atezolizumab + Bevacizumab
    Patients will receive transarterial chemoembolization (TACE) every 3 months, with a maximum of 4 treatments, plus atezolizumab combined with bevacizumab.

Primary Outcome Measure

Proportion of Patients Receiving Liver Transplant Experiencing Acute Rejection [ Time Frame: Within 1 year after liver transplant ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Houston Methodist Research InstituteHoustonTexas77030
Darrel W Cleere, BSN
[email protected]
713-515-8380
Beatriz Efron, BSN
[email protected]
713-363-8890
Maen Abdelrahim, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Houston, TX

By condition
Liver cancer
By specialty
OncologyGI oncologyHepatology
By research site
Houston Methodist Research Institute· Houston, TX

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