Hepatocellular carcinoma
Conditions
Interventions
Transcatheter hepatic arterial infusion - Zoledronic acid (2mg/day)
day-7, 0, 14, 28, 42, 56, 70 - Gamma/delta T cells
0, 14, 28, 42, 56, 70
Sponsors
The University of Tokyo Hospital
Kyoundo Hospital, Sasaki Foundation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Advanced hepatocellular carcinoma patients who are refractory to the standard therapy including sorafenib and meet the following criteria: - Pathological or imaging diagnosis as hepatocellular carcinoma; - No influence by previous treatment; - Life-expectancy is more than 3 months; - Performance Status is 0-1; - No serious abnormality in heart, lung, liver, renal, and bone marrow functions; - Eligible for transcatheter hepatic arterial infusion
Exclusion criteria
Exclusion criteria: Patients who have: - Pulmonary fibrosis or interstitial pneumonia, including their history or predisposition; - Serious drug allergy; - Serious cardiac disease; - Active inflammatory bowel disease, - Active autoimmune disease; - Other cancers; - Active infections; - Pleural effusion or ascite that requires drainage procedure; - Pregnant, to be pregnant, or nursing mothers; - Positive for HIV or HTLV-1;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety | — |
Secondary
| Measure | Time frame |
|---|---|
| In vivo dynamics (Gamma/delta T cells) Pharmacokinetics (Zoledronic acid) Efficacy Immunological responses | — |
Countries
Japan
Contacts
Public ContactKazuhiro Kakimi
The University of Tokyo Hospital Department of Immunotherapeutics
Outcome results
None listed