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

NCT03638141

CompletedPhase 2

Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Conditions: Intermediate Stage of Hepatocellular Carcinoma, Hepatocellular Carcinoma

Interventions: Durvalumab, Tremelimumab

Countries: United States

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.

Eligibility overview

Sex: ALL

Age: 18 Years to

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
Inclusion Criteria:

* 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

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 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.
* 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.
Locations (1)
  • Baltimore, Maryland, United States