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RecruitingLast updated: 2 February 2024

PHITT: This phase III trial is evaluating and comparing different treatment programs, including chemotherapy and targeted therapy, in people with liver cancerPaediatric Hepatic International Tumour Trial

Clinical summary

Summary

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)

Conditions

This trial is treating patients with hepatoblastoma and hepatocellular carcinoma.

Cancer

Upper gastrointestinal tract Cancers Upper gastrointestinal tract

Age

People>30

Phase

III

Trial Acronym

PHITT

More information

Trial Identifiers

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Trial sponsor

University of Birmingham

Scientific Title

Paediatric Hepatic International Tumour Trial

Eligibility

Inclusion

  • 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

  • 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

Exclusion

  • You have been diagnosed with a prior or secondary type of cancer.
  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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