Paediatric Hepatic International Tumour Trial

Launched by UNIVERSITY OF BIRMINGHAM · Jan 10, 2017

Keywords

ClinConnect Summary

The Paediatric Hepatic International Tumour Trial (PHITT) is a clinical study designed to improve treatment for children with two specific liver cancers: Hepatoblastoma (HB) and Hepatocellular Carcinoma (HCC). The trial aims to personalize treatment based on the individual risks of each child, helping doctors provide the most effective care. While children with HB will be treated according to their specific needs, those diagnosed with HCC will be part of a separate group within the trial.

To participate in this trial, children must be diagnosed with HB or HCC, and they should be 30 years old or younger. A key point is that some children may join the trial without having a biopsy if they are too unwell to undergo the procedure safely. Participants will receive careful monitoring and treatment as part of the study, which focuses on finding the best approach for their specific condition. It's important to note that children who have had previous cancer treatments, certain infections, or other serious health issues may not be eligible to join. This trial is currently active, but it is not recruiting new participants at this time.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Clinical diagnosis of HB\* and histologically defined diagnosis of HB or HCC.
• \*Histological confirmation of HB is required except in emergency situations where:
• • a) the patient meets all other eligibility criteria, but is too ill to undergo a biopsy safely, the patient may be enrolled without a biopsy.
• • b) there is anatomic or mechanical compromise of critical organ function by tumour (e.g., respiratory distress/failure, abdominal compartment syndrome, urinary obstruction, etc.)
• • c) Uncorrectable coagulopathy
• • Age ≤30 years
• • Written informed consent for trial entry
• Exclusion Criteria:
• • Any previous chemotherapy or currently receiving anti-cancer agents
• • Recurrent disease
• • Previously received a solid organ transplant; other than orthotopic liver transplantation (OLT).
• • Uncontrolled infection
• • Unable to follow or comply with the protocol for any reason
• • Second malignancy
• • Pregnant or breastfeeding women