Phase 2 Liver Cancer Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• Adults aged 18 or older at the time of joining the study
• People who have been diagnosed with liver cancer (HCC) confirmed by a laboratory examination of tumor tissue
• People who have not previously received any systemic (whole-body) treatment for their liver cancer
• People whose liver cancer is not suitable for locoregional therapy (a treatment that targets a specific area of the body), or who have already completed locoregional therapy at least 28 days before the baseline scan for this study
• People whose liver cancer is classified as Barcelona Clinic Liver Cancer (BCLC) stage B (not suitable for locoregional therapy) or stage C (confirm with trial site for exact staging details)
• People whose liver function is rated as Child-Pugh class A, meaning relatively well-preserved liver function (confirm with trial site)
• People whose general physical condition is rated 0 or 1 on the ECOG scale, meaning they are either fully active or have only minor physical limitations (confirm with trial site)
• People who have at least one measurable tumor that has not been previously treated with radiation, measuring at least 10 mm in its longest dimension (or at least 15 mm for lymph nodes), as seen on a CT or MRI scan
• People whose organs and bone marrow are functioning adequately as assessed by the trial site

Who may not be able to join:

• People who have previously been assigned to a study drug in this same trial
• People who have had radiation treatment covering more than 30% of their bone marrow, or wide-field radiation therapy, within the past 28 days before starting the study drug
• People who have had a major surgical procedure or serious injury within 28 days before the first dose, or any abdominal surgery, abdominal procedures, or serious abdominal injury within 60 days before joining
• People who have previously had an organ transplant, such as a liver transplant
• People who have had a history of hepatic encephalopathy (confusion caused by liver disease) in the past 12 months, or who need medications to prevent it
• People who have a clinically significant build-up of fluid in the abdomen (ascites)
• People who have a blood clot in the main trunk of the portal vein (the main blood vessel supplying the liver), as seen on imaging
• People who currently have symptomatic or uncontrolled high blood pressure
• People who have an active or previously documented autoimmune or inflammatory condition, or diverticulitis — unless the condition has been inactive for 5 years and the study doctor considers participation appropriate
• People who are co-infected with both hepatitis B and hepatitis C viruses, or both hepatitis B and hepatitis D viruses
• People who have a history of another primary cancer, except for certain exceptions defined by the study protocol (confirm with trial site)
• People whose heart's electrical activity shows a prolonged QTcF interval of 470 ms or more, measured across three ECGs
• People diagnosed with specific rare subtypes of liver cancer, including fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC
• People with a history of active primary immunodeficiency (a condition where the immune system does not work properly from birth or early life)
• People who have received a live attenuated vaccine (a vaccine made from a weakened live virus or bacteria) within 30 days before the first dose of the study drug
• People who have had a major gastrointestinal bleed (serious bleeding in the digestive system) within 4 weeks before joining
• People who have untreated or incompletely treated varices (enlarged veins, often in the food pipe) that are bleeding or at high risk of bleeding — specific endoscopy (camera examination) requirements apply and must be confirmed with the trial site
• People who have had significant vascular disease, such as a large aortic aneurysm needing surgery or a blood clot in a peripheral artery, within 6 months before joining
• People who have had a fistula (abnormal connection between organs) in the abdomen or throat/food pipe area, a hole in the gastrointestinal tract, or an abscess (pocket of infection) in the abdomen within 6 months before joining
• People who have evidence of a bleeding disorder or serious problems with blood clotting
• People who have a severe non-healing wound, an active ulcer, or an untreated bone fracture
• People who have used high-dose aspirin (325 mg or more per day) or certain blood-thinning medications (such as clopidogrel, ticlopidine, dipyridamole, or cilostazol) within 10 days before joining
• People who have recently used full-dose blood-thinning or clot-dissolving medications (oral or injected) for treatment purposes within 10 days before joining — preventive use of low-molecular-weight heparin is allowed
• People who are pregnant or breastfeeding, or people of reproductive potential who are not willing to use effective contraception from the screening period until 90 days after the last dose of durvalumab alone, or 180 days after the last dose of the durvalumab plus tremelimumab combination or bevacizumab
• People who have previously taken part in a clinical trial involving durvalumab and/or tremelimumab, regardless of which treatment group they were in

Important: Always verify eligibility with the trial site directly before applying.