Study on Durvalumab and Tremelimumab for Liver Cancer in Patients Awaiting Liver Transplant
Sponsor: Davendra Sohal
ClinicalTrials ID:NCT05027425
This clinical trial is exploring whether a combination of two immunotherapy drugs, Durvalumab and Tremelimumab, can safely help control liver cancer in patients who are waiting for a liver transplant.
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Program Overview
The aim of this study is to see if using the immunotherapy drugs Durvalumab and Tremelimumab can help manage liver cancer in patients who are listed for a liver transplant. Researchers want to find out if this treatment can safely reduce the cancer and improve outcomes for these patients.
Description
This study, known as ESR-20-21010, is a Phase II clinical trial that involves patients with liver cancer (hepatocellular carcinoma) who are also eligible for a liver transplant. The trial will test the safety and effectiveness of two immunotherapy drugs, Durvalumab and Tremelimumab, in these patients.
Participants will receive the immunotherapy treatment for up to four months. After a break of at least 28 days, they will undergo local treatments as per their hospital's standards. Following another break of at least 72 days after the immunotherapy, they will proceed with the liver transplant.
The main goal is to see how many patients experience rejection of the new liver within 30 days after the transplant. The study plans to enroll 30 patients to ensure at least 20 undergo the transplant for proper analysis. An initial review will be conducted after 10 patients to ensure the treatment is safe. If any safety concerns arise, the study may be adjusted or stopped.
Eligibility Criteria
Inclusion Criteria
- Diagnosed with liver cancer (hepatocellular carcinoma) confirmed by biopsy or imaging tests.
- Cancer is limited to the liver with no spread to other parts of the body.
- Evaluated and listed for a liver transplant by the hospital's transplant team.
- At least one measurable tumor that has not been treated with radiation.
- No previous treatment for liver cancer.
- Aged 18 years or older.
- Good overall health with an ECOG score of 0 or 1.
- Child-Pugh score between 5 and 7, indicating liver function.
- Weigh more than 30 kg.
- Have adequate organ and bone marrow function.
- Able to provide informed consent and willing to follow study procedures.
Exclusion Criteria
- Cancer has spread outside the liver.
- Recent variceal bleeding within the last 3 months.
- Autoimmune diseases that pose a risk with immunotherapy.
- Any other medical or logistical issues that could interfere with the study.
- Currently participating in another clinical trial, unless it's non-interventional.
- Recent participation in a trial with an investigational product.
- Major surgery within 28 days before starting the study treatment.
- History of organ transplantation.
- History of another cancer, unless treated and inactive for at least 5 years.
- Active or past autoimmune or inflammatory disorders, with some exceptions.
- Uncontrolled illnesses or infections.
- History of leptomeningeal carcinomatosis.
- Active primary immunodeficiency.
- Active infections, including tuberculosis or hepatitis, unless controlled.
- Recent use of immunosuppressive medication, with some exceptions.
- Recent receipt of a live vaccine.
- Pregnant or breastfeeding women, or those not using effective birth control.
- Known allergy to study drugs.
- Previous participation in a Durvalumab or Tremelimumab study.
- Determined by the investigator to be unsuitable for the study.
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