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Atezolizumab and Bevacizumab Before Liver Transplant for Liver Cancer

This study is looking at whether two drugs, atezolizumab and bevacizumab, can help patients with a type of liver cancer called hepatocellular carcinoma (HCC) who are waiting for a liver transplant. These patients have tumors that are considered "beyond Milan Criteria," meaning they are larger or more numerous than typically allowed for transplant. The study will give you atezolizumab and bevacizumab for up to 6 months while you are on the transplant waiting list. Researchers want to see if this treatment helps you get to transplant without increasing the risk of your body rejecting the new liver within one year after the transplant. To join, you must be at least 18 years old, have HCC that is unresectable and beyond Milan Criteria, and have no cancer spread outside the liver. The study is currently recruiting patients.

Study design
This is an interventional study with a planned enrollment of 24 participants. It is not specified if it is randomized or blinded.
What's involved
You would receive atezolizumab and bevacizumab every three weeks for up to 6 months (up to 8 cycles) during the liver transplant waiting period. You would also provide a baseline tissue biopsy.
Compensation
Not stated in the trial record.
Follow-up
Researchers will measure the proportion of patients who receive a liver transplant and experience acute rejection within 1 year after the transplant.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05185505

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

Recruiting
PHASE4Ages 18+InterventionalTreatment
The Methodist Hospital Research Institute
~24 participants
Updated 2023-02-01 on ClinicalTrials.gov
What's tested:AtezolizumabBevacizumab

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Proportion of Patients Receiving Liver Transplant Experiencing Acute Rejection
Measured over Within 1 year after liver transplant

Conditions

Hepatocellular Carcinoma
Hepatocellular Cancer

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Hepatocellular Carcinoma

NCT05185505

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Houston Methodist Research Institute

    Houston, Texasstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Who to contact

Darrel Cleere, BSN
[email protected]
713-441-6232
Email the study team

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Eligibility criteria

Exclusion

Patients with a history of autoimmune-related hypothyroidism who are on thyroid-replacement hormone are eligible for the study.
Patients with eczema, psoriasis, lichen simplex chronicus, or vitiligo with dermatologic manifestations only (eg, patients with psoriatic arthritis are excluded) are eligible for the study provided all following conditions are met:
Rash must cover \< 10% of body surface area
Disease is well controlled at baseline and requires only low-potency topical corticosteroids
No occurrence of acute exacerbations of the underlying condition requiring psoralen plus ultraviolet A radiation, methotrexate, retinoids, biologic agents, oral calcineurin inhibitors, or high-potency or oral corticosteroids within the previous 12 months 23. History of idiopathic pulmonary fibrosis, organizing pneumonia (eg, bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan. History of radiation pneumonitis in the radiation field (fibrosis) is permitted. 24. Active tuberculosis 25. Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that contraindicates the use of an investigational drug, may affect the interpretation of the results, or may render the patient at high risk from treatment complications 26. Treatment with a live, attenuated vaccine (e.g., FluMist®) within 4 weeks prior to initiation of study treatment, or anticipation of need for such a vaccine during atezolizumab treatment or within 5 months after the final dose of atezolizumab 27. Current treatment with anti-viral therapy for HBV 28. Prior treatment with CD137 agonists or immune checkpoint blockade therapies, including anti-CTLA-4, anti-PD-1, and anti-PD-L1 therapeutic antibodies 29. Treatment with systemic immunostimulatory agents (including, but not limited to, interferon and interleukin 2 \[IL-2\]) within 4 weeks or 5 half-lives of the drug (whichever is longer) prior to initiation of study treatment 30. Treatment with systemic immunosuppressive medication (including, but not limited to, corticosteroids, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-TNF-α agents) within 2 weeks prior to initiation of study treatment, or anticipation of need for systemic immunosuppressive medication during the Treatment Phase, with the following exceptions:
Patients who received acute, low-dose systemic immunosuppressant medication or a one-time pulse dose of systemic immunosuppressant medication (e.g., 48 hours of corticosteroids for a contrast allergy) are eligible for the study after Principal Investigator confirmation has been obtained.
Patients who received mineralocorticoids (eg, fludrocortisone), corticosteroids for chronic obstructive pulmonary disease (COPD) or asthma, or low-dose corticosteroids for orthostatic hypotension or adrenal insufficiency are eligible for the study. 31. History of severe allergic anaphylactic reactions to chimeric or humanized antibodies or fusion proteins 32. Known allergy or hypersensitivity to any component of the Atezlizumab and Bevacizumab formulation, such as a known hypersensitivity to Chinese hamster ovary cell products 33. Inability to comply with study and/or follow-up procedures 34. Active infection requiring IV antibiotics within 2 weeks prior to initiation.
Note: Placement of a vascular access device should be at least 2 days prior to initiation of study treatment.
Patients receiving prophylactic antibiotics (e.g., to prevent a urinary tract infection or chronic obstructive pulmonary disease exacerbation) are eligible for the study. 35. Severe infection within 4 weeks prior to initiation of study treatment, including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia 36. History of leptomeningeal disease 37. Evidence of abdominal free air that is not explained by paracentesis or recent surgical procedure 38. History of intra-abdominal inflammatory process within 6 months prior to initiation of study treatment, including but not limited to active peptic ulcer disease, diverticulitits, or colitis. 39. Chronic daily treatment with a nonsteroidal anti-inflammatory drug (NSAID). Occasional use of NSAIDs for the symptomatic relief of medical conditions such as headache or fever is allowed 40. Uncontrolled tumor-related pain
Patients requiring pain medication must be on a stable regimen at study entry.
Symptomatic lesions (eg, bone metastases or metastases causing nerve impingement) amenable to palliative radiotherapy should be treated prior to enrollment. Patients should be recovered from the effects of radiation. There is no required minimum recovery period.

What this trial measures

  • Proportion of Patients Receiving Liver Transplant Experiencing Acute RejectionWithin 1 year after liver transplant

    The proportion of liver transplant patients who have acute allograft rejection