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

Inclusion Criteria:

- Signed informed consent form

- Age 18-75 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.