Pediatric Hepatic Malignancy International Therapeutic Trial (PHITT)
Sandeep Batra, MD
Primary Investigator
Brief description of study
Detailed description of study
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: liver cancer,hepatoblastoma,childhood hepatocellular carcinoma,childhood malignant liver neoplasm,elevated alpha-fetoprotein,SMARCB1 gene mutation
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Age: - 30 Years
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Gender: All
Inclusion Criteria
Patients must be newly diagnosed with hepatoblastoma or hepatocellular carcinoma
Exclusion Criteria
Prior chemotherapy or tumor directed therapy (i.e. radiation therapy, biologic agents, local therapy (embolization, radiofrequency ablation, and laser); therefore, patients with a pre-disposition syndrome who have a prior malignancy are not eligible
Patients who are currently receiving another investigational drug
Patients who are currently receiving other anticancer agents
Patients with uncontrolled infection
Patients who previously received a solid organ transplant
This criteria apply ONLY to patients who will receive chemotherapy (all groups other than Group E1):
Female patients who are pregnant; a pregnancy test is required for female patients of childbearing potential
Lactating females who plan to breastfeed their infants
Sexually active patients of reproductive potential who have not agreed to use an effective contraceptive method for the duration of their study participation
Note for Group F: patients of childbearing potential should use effective birth control during treatment with sorafenib and for at least 2 weeks after stopping treatment
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