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

Completed · Phase 2

Conditions studied: Intermediate Stage of Hepatocellular Carcinoma, Hepatocellular Carcinoma

In brief

The purpose of this study is to determine the safety and efficacy of immunotherapy durvalumab and tremelimumab combined with DEB-TACE in patients with Hepatocellular Carcinoma.

Key facts

Study ID

NCT03638141

Run by

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

People needed

21

Starts

2019-10-02

Expected to finish

2024-08-20

Last updated by the study team

2025-08-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Signed informed consent form
• Age ≥18 years.
• Patients with diagnosis of HCC either by high-resolution imaging (triple-phase CT or MRI) and/or by tumor biopsy.
• Patient is not on systemic treatment for diagnosis of HCC
• HCC meeting Barcelona Clinic Liver Cancer (BCLC) stage B (intermediate stage), with measurable lesions on CT or MRI and without extrahepatic spread
• Have measurable disease
• Have disease that responds to DEB-TACE
• Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
• Child-Pugh Score of A or early B (score ≤8) without clinically significant ascites
• Body weight >30 kg
• 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

You may not qualify if…

• 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 study drug.
• Have a vascular invasion or extrahepatic tumor.
• Main portal vein thrombosis present on imaging.
• Uncontrolled hepatic encephalopathy at time of enrollment. - Ascites within 6 weeks prior to study treatment.
• Any contraindications for embolization.
• Has an active infection such as Tuberculosis, HIV, hepatitis B or C.
• History of another primary malignancy or myeloproliferative disorder.
• History of leptomeningeal carcinomatosis.
• History of active primary immunodeficiency.
• Any unresolved toxicities from previous anticancer therapy.
• Active or prior documented GI bleeding due to ulcer or esophageal varices bleeding within 6 months.
• History or current use of immunosuppressive medications within 14 days prior to study medications.
• Major surgical procedure within 28 days prior to the first dose of IP.
• 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.

Where it is running

• Sidney Kimmel Comprehensive Cancer Center — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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