AHEP1531, Pediatric Hepatic Malignancy International Therapeutic Trial (PHITT)
Study ID: STU 062018-003
The PHiTT trial is an over-arching study including 4 randomized comparisons addressing therapeutic questions. This trial will use a risk-adapted approach to the treatment of children diagnosed with hepatoblastoma (HB). Children with hepatocellular carcinoma (HCC) will also be included as separate cohorts.
Primary aims 1. To reduce therapy associated toxicity for patients with non-metastatic hepatoblastoma (HB) and hepatocellular carcinoma (HCC) without adversely affecting long term outcomes. 2. To improve the eFS of patients with High Risk HB (Group D) by treating them with interval compressed cisplatin and doxorubicin based induction regimen followed by response-adapted consolidation therapy. 3. in patients with unresectable/metastatic HCC at diagnosis (Group F), to determine whether the addition of gemcitabine and oxaliplatin (GeMoX + sorafenib) to a cisplatin, doxorubicin and sorafenib backbone improves chemotherapy response, resectability and survival.