Hepatocellular carcinoma (HCC)
Conditions
Interventions
Sponsors
Kawasaki Medical School
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Patients who were provided written informed consent. 2)Life expectancy of at least 12 weeks. 3)Histologically proven or clinically diagnosed hepatocellular carcinoma (dynamic CT/MRI). 4)No indication for surgical resection and local ablation. 5)Locally nodular disease without extrahepatic metastasis. Number of tumors are up to 5 (The maximum tumor diameter <= 5 cm). 6)Patients with no or one history of TACE therapy. 7)Performance status (ECOG) of 0-2 8)Child-Pugh class A or B. 9)Patients who fulfill of the inclusion criteria below. a) Hemoglobin >= 8.5 g/dl b) Neutrophil >=1,500 /mm3 c) PLT >= 50,000 /mm3 d) T.Bil <=3.0mg/dl e) ALT, AST <= within 6 times of normal limit f) Cre <= within 1.5 times of normal limit
Exclusion criteria
Exclusion criteria: 1)History of malignant tumor 2)Serious and active infection, except for HBV and HCV 3)History of HIV infection 4)Renal dialysis 5)Diffuse tumor lesion 6)Extrahepatic metastasis 7)Vascular invasion 8)Intracranial tumor 9)Clinically uncontrolled ascites or pleural effusion 10)Clinically severe gastrointestinal bleeding within 4 weeks of the start of treatment 11)Esophageal and/or gastric varices which has high risk of bleeding 12)History of thrombosis and/or embolism within 6 months of the start of treatment 13)History of receiving any of the following therapies: a)Systemic chemotherapy for advanced HCC b)Local therapy within 3 months of the start of treatment c)Invasive surgery within 4 weeks of the start of treatment d)History of allogenic transplantation e)History of bone marrow transplant or haemopoietic stem cell transplant within 4 weeks of the start of this study 14)Concurrent disease or disability that may affect evaluation of the effects of the study drugs 15)Enrollment in another study within 4 weeks of study entry 16)Female patients who are pregnant, lactating, possibly pregnant, or planning to become pregnant 17)Risk of allergic reactions to the study drugs 18)Drug abuse or other physical, psychological , or social problems that may interfere with the participation in the study or evaluation of study results 19)Any condition that could jeopardize the safety of the patient or their compliance in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Tumor response (Treatment effect: TE) | — |
Secondary
| Measure | Time frame |
|---|---|
| Tumor marker change, overall survival, safety, pharmacokinetics (plasma Pt conc.) | — |
Countries
Japan
Contacts
Public ContactYasuyuki Tomiyama
Kawasaki Medical School Department of Hepatology and Pancreatology
Outcome results
None listed