Actively Recruiting
Atezolizumab and Bevacizumab Pre-Liver Transplantation for Patients With Hepatocellular Carcinoma Beyond Milan Criteria
Led by The Methodist Hospital Research Institute · Updated on 2023-02-01
24
Participants Needed
1
Research Sites
247 weeks
Total Duration
On this page
Sponsors
T
The Methodist Hospital Research Institute
Lead Sponsor
G
Genentech, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Atezolizumab and Bevacizumab Pre-Liver Transplantation for Patients With Hepatocellular Carcinoma Beyond Milan Criteria
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female, aged 18 years or older at the time of informed consent
- Measurable or evaluable unresectable hepatocellular carcinoma outside of Milan criteria
- Histologically confirmed hepatocellular carcinoma without disease outside the liver
- Prior remote locoregional therapy allowed if new lesions or recurrence present
- Eligible for liver transplantation
- Suitable to receive transarterial chemoembolization (TACE)
- Child-Pugh score A6 or better
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Life expectancy of at least 6 months
- Adequate blood counts and organ function as defined by specified laboratory values
- No evidence of moderate or higher esophageal or gastric varices; EGD within 6 months prior to treatment
- No significant hemoptysis within 1 month prior to enrollment
- Negative HIV and hepatitis B tests at screening or transplant workup
- Women of childbearing potential must agree to abstinence or highly effective contraception during treatment and for 6 months after final dose
- Men must agree to abstinence or condom use and refrain from sperm donation during treatment and for 6 months after final dose
- Willingness to comply with all study procedures and availability for study duration
- Negative pregnancy test within 14 days prior to starting study treatment for women of childbearing potential
You will not qualify if you...
- Known fibrolamellar, sarcomatoid hepatocellular carcinoma, or mixed cholangiocarcinoma and hepatocellular carcinoma
- Prior systemic therapy for hepatocellular carcinoma before enrollment
- Planned or prior multi-organ, solid organ, or allogeneic stem cell transplant
- History of severe venous thromboembolism (Grade 4 or higher)
- History or evidence of untreated or uncontrolled central nervous system conditions
- Moderate or severe ascites
- History of hepatic encephalopathy
- Uncontrolled hypertension or history of hypertensive crisis
- Significant vascular or cardiovascular disease within specified recent timeframes
- History of bleeding disorders or significant coagulopathy
- Recent major surgery or significant traumatic injury within 28 days prior to treatment
- History of abdominal fistula, gastrointestinal perforation, abscess, or high-risk varices within 6 months
- Untreated or incompletely treated esophageal/gastric varices
- Serious non-healing wounds, active ulcers, or untreated bone fractures
- Other malignancies within 5 years except localized cancer in situ
- Recent use of high-dose aspirin or clopidogrel; certain anticoagulants use restrictions apply
- Pregnancy, lactation, or intent to become pregnant during treatment or within 6 months after final dose
- Uncontrolled pleural, pericardial effusion, or ascites requiring frequent drainage
- Uncontrolled or symptomatic hypercalcemia
- Active or history of significant autoimmune disease or immune deficiency with specified exceptions
- History of certain lung diseases or active pneumonitis
- Active tuberculosis
- Any condition that contraindicates investigational drug use or may increase treatment risk
- Recent live attenuated vaccine use
- Current antiviral therapy for hepatitis B
- Prior immune checkpoint or CD137 agonist therapy
- Recent systemic immunostimulatory or immunosuppressive treatments with exceptions
- History of severe allergic reactions to similar antibodies
- Known allergy to components of atezolizumab or bevacizumab
- Inability to comply with study procedures
- Active infection requiring IV antibiotics within 2 weeks prior to treatment
- Severe infection requiring hospitalization within 4 weeks prior to treatment
- History of leptomeningeal disease
- Evidence of unexplained abdominal free air
- History of intra-abdominal inflammatory conditions within 6 months
- Chronic daily NSAID use, except occasional use for symptom relief
- Uncontrolled tumor-related pain unless stable and treated appropriately
AI-Screening
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Trial Site Locations
Total: 1 location
1
Houston Methodist Research Institute
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
D
Darrel Cleere, BSN
CONTACT
S
Shondra Word
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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