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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 greater than 5cm OR more than three lesions that are greater than 3cm without any vascular invasion or extrahepatic spread; At least 1 measurable lesion at baseline as equal to 10 mm in the longest diameter (except lymph nodes, which must have a short axis equal to 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 equal to 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
12/09/2019 05:03 AM