Paediatric Hepatic International Tumour Trial

Condition(s) studied

Investigational drug(s) / intervention(s)

Cisplatin: Arms A and B - cisplatin is used alone Arms C, D, E and F - cisplatin us used in combination

Doxorubicin: Arms C, D and E used in combination

Carboplatin: Arms C and D used in combination

5Fluorouracil: Arm C used alone

Vincristine: Arms C and D used in combination

Etoposide: Arm D used in combination

Irinotecan: Arm D used in combination

Gemcitabine: Arm F used in combination

Oxaliplatin: Arm F used in combination

Sorafenib: Arm used in combination

Study 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.

Eligibility

Primary outcome measure(s)

• Event-free survival (EFS) — From date of randomisation (or registration into the trial for non-randomised patients), until date of first failure event, assessed up to 6 years.
  Event-free survival (EFS) is defined as the time from randomisation (or registration into the trial for non-randomised patients) to first failure event. Patients who have not had an event will be censored at their last follow-up date. Failure events are: * progression of existing disease or occurrence of disease at new sites, * death from any cause prior to disease progression, * diagnosis of a second malignant neoplasm.
• Response in HCC is defined as complete (CR) or partial (PR) response according to RECIST version 1.1 criteria — From date of screening assessment until date of first response assessment, up to 63 days in Group F
  Response in HCC is defined as complete (CR) or partial (PR) response according to RECIST version 1.1 criteria. The assessment will be performed after 3 cycles of PLADO, or 4 cycles of PLADO+S/GEMOX+S in Group F. Patients who are not assessable for response - e.g. because of early stopping of treatment or death - will be assumed to be non-responders.

Trial sites (32)

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