Pediatric hepatoblastoma and hepatocellular carcinoma
Conditions
Interventions
sorafenib (po) 200mg twice a day 5days irinotecan (iv) 20mg per squaremeters 5 or 10 days.
Sponsors
Kanagawa children's medical center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Hepatoblastoma or hepatocellular carcinoma patients with relapsed or refractory of less than this treatment at the start of age 18 years of age. Before starting this treatment, be enforced two or more types of chemotherapy, 8.2. Partial response or more effects can not be obtained. Patient with unresectable and multiple metastatic lesions Patients and if the image on the tumor can not be detected, the serum AFP level indicates a more than 10 ng ml, and serum AFP level increase continued more two times in the two weeks. In ECOG score PS 0 to 2. Have sufficient organ function, satisfies the following criteria. AST and ALT less than five times the facility criteria TBil 2.0 mg dl less than. Creatinine clearance 71 ml min 1.73 m2 or more There is no abnormality with the treatment 12lead electrocardiogram Consent from was obtained patient or legal representative. 14 days not administered to other chemotherapies.
Exclusion criteria
Exclusion criteria: Active infection controls. Congenital or Acquired immunodeficiency syndrome AIDS . Determined ineligible by doctor.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assessment doselimiting toxicity in combined therapy irinotecan and sorafenib. | — |
Secondary
| Measure | Time frame |
|---|---|
| Ratio of Serious Adverse Event(SAE) AFP rate after chemotherapy Change rate indicated size of tumor and number of lesions after chemotherapy Progression free survival PFS ,Over survival rate(OS) for 6 months | — |
Countries
Japan
Contacts
Public ContactHiroaki Goto
Kanagawa children's medical center Blood and regenerative department
Outcome results
None listed