Study on Atezolizumab and Bevacizumab Before Liver Transplant for Liver Cancer Patients Outside Standard Criteria

Sponsor: The Methodist Hospital Research Institute

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05185505

Provider View

This clinical trial is exploring whether a combination of two drugs, atezolizumab and bevacizumab, can help prepare patients with liver cancer that doesn't meet standard transplant criteria for a liver transplant without increasing the risk of rejection after the transplant.

Patient Parameters

Program Overview

This study is for patients with liver cancer (hepatocellular carcinoma) who are eligible for a liver transplant but have tumors that are too large or advanced to meet the usual criteria for transplantation. The trial will test if a combination of the drugs atezolizumab and bevacizumab, along with standard liver cancer treatment, can shrink the tumors enough to make a transplant possible. The goal is to see if this approach can safely bridge patients to a liver transplant without increasing the risk of rejection within a year after the transplant.

Description

Liver cancer is a leading cause of cancer-related deaths, and liver transplantation is often the best treatment option for patients with advanced liver cancer. However, many patients do not qualify for a transplant because their tumors are too large or advanced. This study aims to help these patients by using a combination of two drugs, atezolizumab and bevacizumab, to shrink the tumors and make them eligible for a transplant.

Atezolizumab is an immunotherapy drug that helps the immune system attack cancer cells, while bevacizumab is a drug that stops the growth of blood vessels that feed tumors. Together, these drugs have shown promise in treating liver cancer in previous studies.

The trial will involve patients receiving these drugs for six months, along with standard liver cancer treatment, to see if their tumors can be reduced to a size that allows for a liver transplant. The study will also monitor the safety of this treatment approach and whether it affects the risk of transplant rejection.

Participants will need to meet certain health criteria and agree to follow the study procedures, including regular medical check-ups and tests. The study aims to provide new treatment options for patients with liver cancer who currently have limited options for a cure.

Eligibility Criteria

Inclusion Criteria

  • Adults aged 18 or older.
  • Have liver cancer that cannot be surgically removed and is outside the standard criteria for a liver transplant.
  • Have a confirmed diagnosis of liver cancer without spread outside the liver.
  • Eligible for liver transplantation and able to undergo standard liver cancer treatments.
  • Have good liver function and overall health, as indicated by specific medical tests.
  • Agree to use effective birth control methods during the study and for six months after treatment.
  • Willing to comply with all study procedures and attend follow-up appointments.

Exclusion Criteria

  • Have a different type of liver cancer or mixed liver cancer.
  • Have received previous systemic therapy for liver cancer.
  • Have a history of severe blood clots or uncontrolled high blood pressure.
  • Have significant heart or blood vessel disease within the past few months.
  • Have a history of severe allergic reactions to similar drugs.
  • Have active infections or other serious medical conditions that could interfere with the study.
  • Are pregnant or breastfeeding, or plan to become pregnant during the study.
  • Are unable to comply with study procedures or follow-up visits.

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