This study wants to find out how well people with high-risk liver cancer tolerate taking durvalumab along with standard chemotherapy drugs gemcitabine and cisplatin before and after surgery. We also want to learn whether this combination of treatments helps people with liver cancer that can be removed by surgery live longer.
Durvalumab is a medicine that may help the immune system stop tumor cells from growing and spreading. Chemotherapy drugs like gemcitabine and cisplatin kill cancer cells or stop them from spreading. When these medicines are given together before surgery, they may shrink the tumor and help protect more of the healthy liver in people with high-risk liver cancer. If you join this study, you will get the study medicines, durvalumab, gemcitabine, and cisplatin, for up to 12 weeks. After the first 6 weeks, you will have imaging scans and visit your doctor to check if your tumor has grown. If it has grown, you and your doctors will talk about the next best steps, which may be stopping the study. After you finish the 12 weeks of treatment, your doctors will check to make sure that you are healthy enough for surgery. After you recover from surgery, your doctors will decide if you can keep getting the study medicines for 12 more weeks. You will have one visit each week before and after your surgery, for a total of 8 visits. At these visits, you will get the study medicines, have a physical exam, and have your weight and vital signs checked. You will also give blood samples so the study team can check your blood count and overall health. The study team will ask about any medicines you are taking and any side effects you notice. You may also have imaging scans to check the size of your tumor and if your cancer has spread. After you stop treatment, your doctor will keep watching your health and checking for side effects. You will have visits to the office every 6 months for five years, and once a year after that. You and your insurance will need to pay for your routine medical care. You will not be paid for being in this study.
You may be able to join this study if you are 18 years or older and have high-risk liver cancer that can be removed with surgery. You must have at least one tumor larger than 10 mm that has been confirmed by imaging or a medical exam. You also need to have healthy organs and bone marrow, based on blood tests, and a life expectancy of more than 12 weeks. More eligibility information is listed on ClinicalTrials.gov. Your doctor or a study team member will review these requirements with you. You can click on the NCT number link below to learn more about this study on ClinicalTrials.gov.
Protocol Number: 24-0573
More information available at ClinicalTrials.gov: NCT06050252
Principal Investigator