Liver cancer
Conditions
Interventions
intra-tumor injection of Ad-SGE-REIC three times with two weeks interval level 1: 3.0x10^11 vp(viral particle) level 2: 1.0x10^12 vp level 3: 3.0x10^12 vp
Sponsors
Okayama University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Histological confirmed hepatocellular carcinoma or liver metastasis of pancreatic cancer Ability to understand and the willingness to sign a written informed consent document Patients must have measurable disease. Patient refractory to or intolerant of standard therapy Life expectancy over 3 months Neutrophil count >= 1000/uL Hemoglobin >= 8.5g/dL Platelets >= 60,000/uL Albumin >= 2.8 g/dL Total bilirubin =< 2x institutional upper limit of normal AST =< 5x institutional upper limit of normal ALT =< 5x institutional upper limit of normal INR 0.8 - 2x institutional upper limit of normal Creatinine =< 2 x institutional upper limit of normal ECOG performance status of 0 or 1 Child-Pugh scale =< 7 Patient must agree to use adequate contraception
Exclusion criteria
Exclusion criteria: Patient with active bacterial, fungal or viral infections. Hepatitis B or C is allowed Patient with brain metastasis Patient with other malignancies HIV-positive Patient with angina pectoris, congestive heart failure, or myocardial infarction less than 1 year previously Patient with psychiatric illness that would limit compliance with study requirements Pregnant women, women suspect she is pregnant, or lactating woman Patient have a history of allergic reactions against drugs used in this study Any experimental anti-cancer drug therapy within 4weeks prior to this study Any anti-cancer drug therapy within 4 weeks prior to this study Patient received topical therapy within 4 weeks prior to this study Patient on anticoagulation or antiplatelet therapy Poor glycemic control measured as HbA1C >8.0 Patient is on chronic systemic steroid therapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assessment of safety | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective Response Rate (ORR) Disease Control Rate (DCR) | — |
Countries
Japan
Contacts
Public ContactHidenori Shiraha
Okayama University Hospital Department of Gastroenterology and Hepatology
Outcome results
None listed