RecruitingHepatocellular CarcinomaHepatocellular Cancer
Atezolizumab and Bevacizumab Pre-Liver Transplantation for Patients With Hepatocellular Carcinoma Beyond Milan Criteria
Eligible age
18+ yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
No
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About this study
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.
Sponsor: The Methodist Hospital Research Institute
You may qualify if…
- ✓ 1. Male or female, aged ≥18 years old at the time of signing Informed Consent Form
- ✓ 2. Measurable or evaluable disease per RECIST v1.1 or mRECIST of unresectable HCC outside of Milan criteria
- ✓ 3. Histologically proven HCC, without extrahepatic disease. Patients who consent to a fresh tissue biopsy, and under the discretion of the Investigators, will provide a baseline biopsy sample for diagnosis and correlative studies. Archival tumor tissue may be used to confirm HCC in patients who do not consent to a fresh tissue biopsy.
- ✓ 4. Prior remote LRT is allowed if new lesions or local disease recurrence are present
- ✓ 5. Must be eligible for liver transplantation, defined in Section 10.4
- ✓ 6. Eligible and suited to receive TACE procedure(s)
- ✓ 7. Child-Pugh score ≤A6
- ✓ 8. Eastern Cooperative Oncology Group (ECOG) score 0-1
You may not qualify if…
- ✕ 1. Known fibrolamellar HCC, sacromatoid HCC, or mixed cholangiocarcinoma and HCC
- ✕ 2. Previous systemic therapy for HCC prior to study enrollment
- ✕ 3. Planned or prior multi-organ transplant or prior solid organ or allogeneic stem cell transplantation
- ✕ 4. History of Grade ≥4 venous thromboembolism
- ✕ 5. History or evidence upon physical or neurological examination of central nervous system (eg seizures) unrelated to cancer unless adequately treated with standard medical therapy. Anticonvulsants (stable dose) are allowed.
- ✕ 6. Moderate or severe ascites
- ✕ 7. History of hepatic encephalopathy
- ✕ 8. Inadequately controlled hypertension (defined as systolic blood pressure \>150 mmHg and/or diastolic blood pressure \>100 mmHg)
Where it's recruiting
Texas
Houston
Source: ClinicalTrials.gov · NCT05185505 · last updated 2023-02-01