Paediatric Hepatic International Tumour Trial

• Status: Recruiting
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The PHITT trial is an over-arching study for patients with Hepatoblastoma (HB) and Hepatocellular Carcinoma (HCC). This trial will use a risk-adapted approach to the treatment of children diagnosed with HB.

Children with HCC will be included as a separate cohort.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Birmingham
• Collaborators: Fundació Institut Germans Trias i Pujol; Medical University of Gdansk; University Hospital Munich; University Hospital Tuebingen; University Hospital, Bonn; University of Kiel; University of Newcastle Upon-Tyne; University of Padova; University of Padua
• Treatments: Carboplatin; Cisplatin; Doxorubicin; Etoposide; Etoposide phosphate; Fluorouracil; Gemcitabine; Irinotecan; Liposomal doxorubicin; Oxaliplatin; Sorafenib; Vincristine

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