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PHITT : Paediatric Hepatic International Tumour Trial

Male or<br/>FemaleGender Male or

RecruitingStatus Recruiting

Systemic<br/>Therapy TrialTypeSystemic
Therapy Trial

ThreePhase Three

<30Age Under 30

Liver<br/>CancersCancer LocationLiver

Systemic therapy | Stomach and upper gastrointestinal tractLiver

Trial Overview Read MoreRead more

This phase III trial is evaluating and comparing different treatment programs, including chemotherapy and targeted therapy, in people with liver cancer.

This trial is treating patients with hepatoblastoma and hepatocellular carcinoma.

This is a systemic therapy trial.

You may be excluded from this trial if:

  • You have a certain disease or psychological condition.
  • You have been diagnosed with a prior or secondary type of cancer.
  • You have had certain treatments, surgical procedures or drugs.

Clinical trials have complex eligibility criteria - talk to your doctor about your interest in this trial.

Clinical Summary Read MoreRead more

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

Scientific Title

Paediatric Hepatic International Tumour Trial

Other Non-Commercial Sponsor

University of Birmingham


This trial has several arms (groups), and participants will be allocated based on their diagnosis. Group A will consist of participants with Very Low Risk Hepatoblastoma (HB), and they will receive 2 cycles of Cisplatin (2x100mg/m2). Group B will consist of participants with Low Risk HB. Participants who are have their tumours removed with surgery after 2 cycles of Cisplatin will be randomised to receive 4 or 6 cycles of Cisplatin overall (80mg/m2). Participants who do not undergo surgery will continue to receive up to 6 cycles of Cisplatin (80mg/m2) until surgery. Group C will consist of participants with Intermediate Risk HB. Participants will be randomised to receive Cisplatin (80mg/m2), Carboplatin (500mg/m2) and Doxorubicin (60mg/m2) as SIOPEL-3HR (5 cycles), Cisplatin (100mg/m2), Doxorubicin (60mg/m2) 5-Fluorouracil (600mg/m2) and Vincristine (4.5mg/m2) as C5VD (6 cycles), or 6 cycles of high dose Cisplatin (100mg/m2). Group D will consist of participants with High Risk HB. Participants will receive SIOPEL-4 regimen (Cisplatin 70mg/m2, Doxorubicin 30mg/m2) then have surgery. Post surgery, patients with remaining metastases will be randomised to receive 6 cycles of either Carboplatin (500mg/m2) and Doxorubicin (40mg/m2) alternating with Carboplatin (800mg/m2) and Etoposide (400mg/m2), or Carboplatin (500mg/m2) and Doxorubicin (40mg/m2) alternating with Vincristine (3mg/m2) and Irinotecan (250mg/m2). Patients with no metastases will receive the standard treatment of 3 cycles of Carboplatin (500mg/m2) and Doxorubicin (40mg/m2). Group E will consist of those with Hepatocellular Carcinoma (HCC) that has been removed in surgery. Patients with an underlying predisposition to HCC through genetic, viral or metabolic conditions will be followed up (no intervention). De novo or fibrolamellar HCC patients will receive 4 cycles of PLADO regimen (Cisplatin (80mg/m2) and Doxorubicin (60mg/m2)) over 4 cycles. Group F will consist of those with HCC that has not been removed in surgery. Participants will be randomised to receive up to 6 cycles of PLADO (Cisplatin 80mg/m2, Doxorubicin 60mg/m2) with Sorafenib (300mg/m2) or up to 8 cycles of PLADO with Sorafenib and GEMOX (Gemcitabine 1000mg/m2, Oxaliplatin 100mg/m2) with Sorafenib (300mg/m2)

Recruiting Hospitals Read MoreRead more

Royal Childrens Hospital
Trial Coordinator

Trial Overview: General information about a clinical trial. This section provides an overview of who might be able to join this trial and what type of treatment is involved.