CTLA-4 /PD-L1 Blockade Following Transarterial Chemoembolization (DEB-TACE) in Patients With Intermediate Stage of HCC (Hepatocellular Carcinoma) Using Durvalumab and Tremelimumab

This is an interventional treatment trial for Intermediate Stage of Hepatocellular Carcinoma focused on measuring HCC, Durvalumab, Tremelimumab, Immunotherapy, PD-L1, Antibodies, Hepatocellular Carcinoma, CTLA-4, DEB-TACE Read More

Inclusion Criteria:

• Signed informed consent form
• Age ≥18 years.
• Newly diagnosed with hepatocellular carcinoma
• Have measurable disease
• Have disease that responds to DEB-TACE
• Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
• Body weight >30 kg
• Evidence of clinical or radiographic ascites with a score < 7
• Patients must have adequate organ function defined by study-specified laboratory tests.
• Evidence of post-menopausal status or negative pregnancy test
• Willing and able to comply with study procedures
• Willing to undergo a liver biopsy

Exclusion Criteria:

• Anyone involved with the planning and/or conduct of the study.
• Has participated in another investigational study during the last 6 months.
• Any concurrent anticancer therapy or received therapy ≤30 days prior to study.
• Major surgical procedure at the time of study enrollment or within 28 days prior to the first dose of IP.
• Have a diffuse HCC (Hepatocellular Carcinoma), vascular invasion or extrahepatic tumor.
• Main portal vein thrombosis present on imaging.
• History of hepatic encephalopathy within past 12 months or require medications to prevent or control encephalopathy.
• Ascites within 6 weeks prior to study treatment.
• Any contraindications for embolization.
• Has an active infection such as TB, HIV, hepatitis B or C.
• History of another primary malignancy.
• History of leptomeningeal carcinomatosis.
• History of active primary immunodeficiency.
• Any unresolved toxicities from previous anticancer therapy.
• Grade ≥2 neuropathy.
• History of bleeding disorder.
• History or current use of immunosuppressive medications within 14 days prior to study medications.
• Has an active known or suspected autoimmune disease.
• Patients with hypothyroidism.
• Any active skin conditions.
• History of allogenic organ transplantation.
• Significant heart disease.
• Patients weighing < 30 kg.
• Patients with celiac disease not controlled by diet alone.
• Patient with uncontrolled intercurrent illness including, but not limited to, uncontrolled infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
• Have received a live vaccine within 30 days prior to study drug.
• Woman who are pregnant or breastfeeding.
• Known allergy or hypersensitivity to the study drug.
• Have received durvalumab, tremelimumab, anti-PD-1, anti-PD-L1 or anti-CTLA-4 in a prior study.
• Unwilling or unable to follow the study schedule for any reason.