Hepatocellular carcinoma with major vascular invasion
Conditions
Interventions
1) Stereotactic body radiotherapy, 48Gy/4Fr toward the portion of vascular invasion of the tumor. 2) Seven to 28 days after radiotherapy, the molecularly-targeted agent is started. The sorts of mole
Sponsors
Osaka International Cancer Institute
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: The eligible subject must; 1) Be able to provide written informed consent from the subject person. 2) Have no previous molecularly-targeted therapies or systemic chemotherapies. 3) Have an ECOG-PS 0 or 1. 4) Have the liver function of a Child-Pugh class A (5-6 points), or Child-Pugh score 7 points with serum albumin of 3.0-3.5 g/dl and prothrombin time of 60-70%. 5) Fulfill the following the values of laboratory testings within 14 days prior to the trial registration. Neutrophils > 1500/mm^3, Hemoglobin > 8.5 g/dl, Platelets > 60000/mm^3, AST < x5 ULN, ALT < x5 ULN, Serum creatinine < 1.3 mg/dl, Creatinine clearance < 60 ml/min. 6) Received no treatments for HCC within 28 days prior to the trial registration. 7) Have a predicted life expentancy of 8 weeks or more.
Exclusion criteria
Exclusion criteria: The subject must be excluded if the subject; 1) Has the hepatic encephalopathy 2) Has the uncontrollable hypertension, heart failure, ischemic heart disease or arrhythmia. 3) Has had the acute myocardial infarction in the last 6 months. 4) Has the synchronous malignancies of other organs, or has had the metachronous ones in the last 2 years. 5) Has the serious psychiatric disorder or a serious decline in cognitive function. 6) Is pregnant or breastfeeding, or a female expecting to conceive a child. 7) Is judged to be inappropriate for the entry of this trial in the opinion of the treating investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety; occurrence rate of adverse events, occurrence rate of adverse events of grade 3 or more. | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy; overall survival rate, progression-free survival, response rate, disease control rate | — |
Countries
Japan
Contacts
Public ContactKazuyoshi Ohkawa
Osaka International Cancer Institute Department of Hepatobiliary and Pancreatic Oncology
Outcome results
None listed