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Title:
J18118 - The effect of CTLA4/PDL-1 Blockade following drug-eluting bead transarterial chemoembolization (DEB-TACE) in patients with intermediate stage of HCC using Durvalumab (MEDI4736) and Tremelimumab
Protocol Number:
J18118
Phase:
Phase II
Physician:
Ana De jesus-acosta
Sites:
Johns Hopkins Kimmel Cancer Center in Baltimore
Purpose:
A goal of this research study is to see if durvalumab given with tremelimumab helps to shrink the cancer when given between DEB-TACE procedures. Other goals of the study are to test whether these drugs cause any significant side effects and how a person’s immune system responds to the drugs. In addition, we will have 20 patient data from our institutional database as exact matched control based on age, gender, tumor stage and Child-pugh score. We will evaluate the objective response rate (ORR) in comparison to the study group, using Mcnamara paired-sample test.
Eligibility:
Inclusion Criteria: Patient with diagnosis of HCC either by high-resolution imaging (triple-phase CT or MRI) and/or by tumor biopsy. Patients with diagnosis of HCC either by high-resolution imaging (triple-phase CT or MRI) and/or by tumor biopsy; ECOG performance status 0-1; BCLC)stage B (intermediate stage)with tumor burden greater than single lesion >5cm OR more than three lesions that are >3cm without any vascular invasion or extrahepatic spread; At least 1 measurable lesion at baseline as =10 mm in the longest diameter (except lymph nodes, which must have a short axis =15 mm) with CT or MRI per modified RECIST guidelines;Child Pugh score of A or early B (score equal or lower 7; Adequate end-organ function as manifested by blood test following the protocol criterial; Body weight great 30kg; • Patient who is willing to get percutaneous liver biopsy. Exclusion Criteria: •Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site). •Participation in another clinical study with an investigational product during the last 6 months. •Any concurrent anticancer therapy (chemotherapy, immunotherapy, endocrine therapy, targeted therapy, biologic therapy, tumour embolization, monoclonal antibodies) or receipt of the last dose =30 days prior to the baseline scan. Concurrent use of hormonal therapy for non–cancer-related conditions (e.g., hormone replacement therapy) is acceptable. •Patients who are being considered for a surgical resection or liver transplantation at the time of enrollment.
Treatment:
This is an open-label, single institution study of combination treatment of tremelimumab and durvalumab with trans-arterial chemoembolization with drug-eluting microsphere beads (DEB-TACE) in patients with intermediate stage HCC. The purpose of this study is to determine the safety and efficacy of durvalumab and tremelimumab in this population who are receiving DEB-TACE as standard of care. Patients who have intermediate stage HCC according to Barcelona Clinic Liver Cancer (BCLC) criteria, who are eligible for locoregional treatment with DEB-TACE will be enrolled. There are two cohorts, A and B. The cohort A will undergo DEB-TACE, followed by Durvalumab IV in combination with tremelimumab IV (Cohort A dose)The cohort B will undergo DEB-TACE, followed by Durvalumab IV in combination with tremelimumab IV (Cohort B dose)until progression of disease or the end of study.
Population:
Adult
Last Update
03/05/2019 05:03 AM