Active not recruitingPHASE3INTERVENTIONAL

Paediatric Hepatic International Tumour Trial

The PHITT study is looking for children and young people up to 30 with liver cancers called hepatoblastoma (HB) and hepatocellular carcinoma (HCC). We want to improve treatments for these cancers. For HB, we're testing if less treatment works for low-risk cases, reducing side effects, and if more intense treatment with new medicines helps high-risk cases. For HCC, we’re comparing treatments based on whether the cancer can be removed by surgery. We're also collecting samples to understand the cancers better and predict who might have side effects from chemotherapy. Our goal is to find safer and more effective treatments for these specific liver cancers.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

University of Birmingham

Enrolment target

450

Start

24 Aug 2017

Estimated completion

01 Dec 2027

Hepatoblastoma Carcinoma, Hepatocellular

What is this study about?

The PHITT study is an important research project for children and young people up to 30 years old who have certain types of liver cancer. These are called hepatoblastoma (HB) and hepatocellular carcinoma (HCC). The main goal is to find the best way to treat these cancers, making sure children get enough treatment to be effective, but not so much that they suffer unnecessary side effects.

For children with hepatoblastoma, the study looks at different treatment plans depending on how risky their cancer is. If the cancer is considered low-risk, doctors want to see if a shorter course of chemotherapy can be just as effective as a longer one, which would mean fewer side effects for the child. For those with high-risk cancer, the study explores stronger treatments using newer medicines. For cases that are somewhere in the middle, doctors are comparing three different treatment plans to see which one works best and has the fewest side effects.

For children with hepatocellular carcinoma, the study divides them into groups based on whether their cancer can be removed by surgery or if it has spread. This helps doctors compare treatments more effectively for different situations. A big part of this study also involves collecting blood and tissue samples. This helps researchers understand the cancers better, find out why some treatments work well for certain children, and even predict who might have more side effects from chemotherapy. Ultimately, this research aims to improve how we treat these specific liver cancers, making treatments safer and more successful.

Key takeaways

Targets liver cancers: hepatoblastoma (HB) and hepatocellular carcinoma (HCC) in young people up to 30.
Aims for tailored treatment: less for low-risk, more for high-risk patients to improve outcomes and reduce side effects.
Compares different treatment plans for various cancer situations.
Collects samples to better understand liver cancers and predict treatment responses.
Seeks to establish the world's largest collection of samples for these pediatric liver cancers.

Who may be eligible?

This study is looking for children and young people up to 30 years old who have been diagnosed with a liver cancer called hepatoblastoma (HB) or hepatocellular carcinoma (HCC). Usually, doctors need to confirm the cancer type with a small tissue sample, but if a child is too unwell for this, they might still be able to join the study.

There are also some reasons why someone might not be able to join. For example, if they've already had chemotherapy for their cancer, or if the cancer has come back after previous treatment. If a child has received an organ transplant (other than a liver transplant), or has an uncontrolled infection, or another type of cancer, they wouldn't be able to participate. Also, pregnant or breastfeeding women cannot join this study.

Before deciding, it's very important to talk to your child's doctor or the study team. They can explain all the details and confirm if your child meets the specific requirements for taking part.

Quick self-check

Is your child 30 years old or younger?
Has your child been diagnosed with hepatoblastoma (HB) or hepatocellular carcinoma (HCC) liver cancer?
Has your child NOT received any chemotherapy treatment for this cancer yet?
Has your child NOT had an organ transplant (other than a liver transplant)?
Is your child NOT pregnant or breastfeeding (for female patients)?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

Taking part in this study means your child will receive one of the specific treatment plans being tested, which involves medications like Cisplatin, Doxorubicin, and others. The exact number of visits, tests, and how long your child is followed up will depend on the specific treatment group and their cancer type. For example, some groups might have shorter treatment plans. The study also involves collecting blood and tissue samples at different times to help researchers understand the cancer better. This doesn't usually mean extra visits, as these are often done during routine check-ups. The total duration someone is involved in the study can vary, but generally, there will be follow-up appointments after the main treatment ends to monitor your child's health.

Potential risks and benefits

Participating in this study might offer your child access to new or different treatment approaches that could be more effective or have fewer side effects than standard treatments, especially for certain types of liver cancer. However, all medical treatments carry risks, and the medications used in this study, like chemotherapy medicines, can have side effects. These will be fully explained by your child's medical team. It's important to remember that joining the study is entirely voluntary, and you have the right to withdraw your child at any time without affecting their future medical care.

Locations (32)

St. Anna Kinderspital
Vienna, Austria
Cliniques Universitaires Saint-Luc
Brussels, Belgium
University Hospital Motol
Prague, Czechia
Kuopio University Hospital
Kuopio, Finland
CHU de Rennes
Rennes, France
Ludwig-Maximillians-University Munich
Munich, Germany
Children's Health Ireland Crumlin
Dublin, Ireland
Schneider Children's Medical Center
Petah Tikva, Israel
Prinses Maxima Center
Utrecht, Netherlands
Oslo University Hospital
Nydalen, Norway
Medical University of Gdansk
Gdansk, Poland
University Hospital Reina Sofia
Córdoba, Spain

+20 more sites — see the official record for the full list.

Common questions

What is hepatoblastoma (HB) and hepatocellular carcinoma (HCC)?

These are two types of liver cancer that can affect children and young people.

What is a 'risk-adapted approach' to treatment?

This means your child's treatment plan will be specifically designed based on how serious or 'risky' their cancer is deemed to be.

What are 'novel agents' in treatment?

These are new or experimental medications that are being tested to see if they can help treat more difficult cancers.

Why are you collecting blood and tissue samples?

Collecting samples helps doctors understand the cancers better, how they respond to treatment, and predict who might have side effects, leading to better care in the future.

Can my child join if they've had chemotherapy before?

No, children who have already received chemotherapy for their cancer are generally not eligible for this study.