hepatoblastoma and hepatocellular carcinoma of children
Conditions
Interventions
irinotecan i.v. at 20 mg/m2 x 5 or 10 days combined with sorafenib at 400 mg/m2 x 28 days
Sponsors
Kanagawa Children's Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients who have not achieved PR or CR by 2 different chemotherapy regimens before enrollment 2. with unresectable or metastatic diseases (or with abnormal serum AFP>10 ng/ml which has elevated in 2 consecutive evaluation with at least 2 weeks interval) 3. ECOG PS score = 0 - 2 4. with normal organ function 5. with informed consent 6. no other chemotherapy has been administered 14 days before enrollment.
Exclusion criteria
Exclusion criteria: 1. active infectious disease 2. congenital or acquired immunodeficiency 3. inadequate case by physician's judgement
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dose limiting toxicity in the sorafenib + irinotecan combination therapy | — |
Secondary
| Measure | Time frame |
|---|---|
| occurrence of adverse events AFP after the treatment tumors size/number after the treatment 6 months non-progress survival/overall survival | — |
Countries
Japan
Contacts
Public ContactHiroaki Goto
Kanagawa Children's Medical Center Division of Hemato-Oncology and Regenerative Medicine
Outcome results
None listed