Active — Not RecruitingPhase 3

Paediatric Hepatic International Tumour Trial

Austria, Belgium, Czechia450 participantsStarted 2017-08-24

Plain-language 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.

Who can participate

Age range

30 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Event-free survival (EFS)

Timeframe: From date of randomisation (or registration into the trial for non-randomised patients), until date of first failure event, assessed up to 6 years.

Response in HCC is defined as complete (CR) or partial (PR) response according to RECIST version 1.1 criteria

Timeframe: From date of screening assessment until date of first response assessment, up to 63 days in Group F

Trial details

NCT IDNCT03017326

SponsorUniversity of Birmingham

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-12-31

View on ClinicalTrials.gov More Hepatoblastoma trials