AHEP1531: Pediatric Hepatic Malignancy International Therapeutic Trial (PHITT)

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions:
    Hepatoblastoma Or Hepatocellular Carcinoma
  • Age: Between 0 years - 30 years
  • Gender: Male or Female
  • Other Inclusion Criteria:
    To be considered for this trial the following cafeterias must be met: 1) Patients with a diagnosis of hepatocellular neoplasm, not otherwise specified, should be classified and treated per hepatoblastoma treatment arms. Please see the tables below for risk stratification of hepatoblastoma and hepatocellular carcinoma patients in this study. Note that rapid central pathology review is required in some cases. 2) Patients must be newly diagnosed with histologically-proven primary pediatric hepatic malignancies including hepatoblastoma or hepatocellular carcinoma. 3) Normal pulmonary function tests (including DLCO) if there is clinical indication for determination (e.g. dyspnea at rest, known requirement for supplemental oxygen). For patients who do not have respiratory symptoms or requirement for supplemental oxygen, PFTs are NOT required.

You may not be eligible for this study if the following are true:

  • You will not be eligible for this trial if you have the following: 1) Prior chemotherapy or tumor directed therapy except for surgical resection of the hepatic malignancy (i.e., radiation therapy, biologic agents, local therapy (embolization, radio frequency ablation, and laser)). Therefore, patients with a pre-disposition syndrome who have a prior malignancy are not eligible. 2) Patients who are currently receiving another investigational drug. 3) Patients who previously received a solid organ transplant, other than those who previously received an orthotopic liver transplantation (OLT) as primary treatment of their hepatocellular carcinoma. 4) Patients who have known deficiency of dihydropyrimidine dehydrogenase (DPD).

If you are registered as a volunteer, please log in to contact the study team/express interest in this study.