Study on TheraSphere with Durvalumab and Tremelimumab for Liver Cancer (HCC)

Inclusion Criteria

• Must be 18 years or older.
• Must provide written informed consent.
• Must have a life expectancy of at least 6 months.
• Must have liver cancer (HCC) confirmed by imaging or biopsy.
• Not eligible for liver surgery, thermal ablation, or transplant.
• Must have a performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
• Must have measurable disease by specific criteria.
• Tumor must occupy 35% or less of the liver.
• Must have a sufficient amount of healthy liver tissue remaining.
• Must meet specific dosimetry criteria for treatment.
• Previous liver surgery or ablation must have been completed at least 6 months prior.
• Previous transarterial chemoembolization (TACE) is allowed if it was done at least 8 months prior, resulted in complete response, and the current tumor is not a recurrence.
• Patients with certain types of portal vein thrombosis are eligible.
• Patients with hepatitis B or C must have controlled infection.
• Patients with HIV must have well-controlled infection.
• Women of childbearing potential must have a negative pregnancy test and use effective contraception.
• Must have adequate kidney and bone marrow function.
• Must have adequate liver function.
• Must weigh more than 30 kg and have a BMI of at least 18 kg/m2.

Exclusion Criteria

• Cannot have conditions that prevent safe angiography or catheterization.
• Cannot have certain imaging results that show risk to the gastrointestinal tract or poor targeting of the tumor.
• Cannot have blood shunting to the lungs that exceeds safe radiation levels.
• Cannot have certain types of vein invasion or metastases outside the liver.
• Cannot have had previous systemic treatment for liver cancer.
• Cannot have had previous immune therapy for other diseases.
• Cannot have had previous liver radiation.
• Cannot be receiving other treatments for liver cancer or be in another interventional study.
• Cannot have hepatic encephalopathy or recent episodes of it.
• Cannot have liver cancer that cannot be evaluated by specific criteria.
• Cannot have severe lung problems or recent pneumonitis.
• Cannot have a history of organ transplants.
• Cannot have active or prior autoimmune or inflammatory disorders, with some exceptions.
• Cannot have used immunosuppressive medication recently, with some exceptions.
• Cannot have had recent gastrointestinal bleeding or certain bleeding disorders.
• Cannot have a biliary stent or sphincterotomy within the past year.
• Cannot have had another cancer within the past three years, with some exceptions.
• Cannot have had major surgery recently.
• Cannot have severe allergies to study drugs or their components.
• Cannot have active infections, including tuberculosis or certain viral infections.
• Cannot have received a live vaccine recently.
• Cannot be pregnant or breastfeeding.
• Cannot have unstable chronic disease or conditions that pose undue risk.
• Must be able to follow treatment requirements.

For France Patients Only:

• Cannot be deprived of liberty or under certain legal protections.