A Phase II/III Study of Pediatric Liver Cancer Treatments

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Full Title

AHEP1531, Pediatric Hepatic Malignancy International Therapeutic Trial (PHITT) (CIRB)

Purpose

The purpose of this study is to evaluate several new approaches to treating liver cancers (hepatoblastoma and hepatocellular carcinoma) in children, adolescents, and young adults. Patients will be placed in a treatment group according to their type of liver cancer and how aggressive it may be (i.e., low, intermediate, or high risk, operable, inoperable, or metastatic). This study includes groups for children with these types of cancers:

  • Very low-risk hepatoblastoma
  • Low-risk hepatoblastoma
  • Intermediate-risk hepatoblastoma
  • High-risk hepatoblastoma
  • Initially operable hepatocellular carcinoma
  • Initially inoperable or metastatic hepatocellular carcinoma

The treatments include a combination of intravenous chemotherapy (given by vein) and oral drugs (taken by mouth), depending on which group a patient is placed in. In some cases, patients will not receive chemotherapy after surgery, but will be observed. Other patients will receive chemotherapy before surgery to see if it shrinks the tumor enough to make it operable.

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • This study is for patients age 30 and younger.
  • Patients must have hepatoblastoma or hepatocellular carcinoma.
  • Prior liver cancer surgery is permitted, but patients may not have received any other treatment for liver cancer.
  • Patients must be able to walk and do routine activities for more than half of their normal waking hours.

For more information about this study and to inquire about eligibility, please contact Dr. Michael Ortiz at 212-639-6057.

Protocol

18-452

Phase

II/III

Disease Status

Newly Diagnosed & Relapsed/Refractory

Investigator

Co-Investigators