HepatoblastomaPhase 3PHITTNCT03017326
Paediatric Hepatic International Tumour Trial
A Phase 3 study testing Cisplatin, Doxorubicin and Carboplatin in people with Hepatoblastoma and Carcinoma, Hepatocellular, run by University of Birmingham at 32 sites in 14 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 30 years
- Conditions the study is for
- Hepatoblastoma, Carcinoma, Hepatocellular
- What is being tested?
- Cisplatin, Doxorubicin and Carboplatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 450 participants
- Where
- 32 sitesin 14 countries
- Study dates
- 24 Aug 2017to Dec 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 30 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
32 sites in 14 countries.
32 sites in 14 countries
United Kingdom19 sites
Royal Aberdeen Children's Hospital
Aberdeen, AB25 2ZG
Royal Belfast Hospital for Sick Children
Belfast, BT12 6BE
Birmingham Children's Hospital
Birmingham, B4 6NH
Bristol Royal Hospital for Children
Bristol, BS2 8BJ
Addenbrooke's Hospital
Cambridge, CB2 0QQ
Noah's Ark Children's Hospital for Wales
Cardiff, CF14 4XW
Royal Hospital for Children
Edinburgh, EH9 1LW
Royal Hospital for Children
Glasgow, G51 4TF
Leeds General Infirmary
Leeds, LS1 3EX
Leicester Royal Infirmary
Leicester, LE1 5WW
Alder Hey Children's Hospital
Liverpool, L12 2AP
Great Ormond Street Hospital
London, WC1N 3JH
Royal Manchester Children's Hospital
Manchester, M13 9WL
Great North Children's Hospital
Newcastle upon Tyne, NE1 4LP
Nottingham Children's Hospital
Nottingham, NG7 2UH
Oxford Children's Hospital
Oxford, OX3 9DU
Sheffield Children's Hospital
Sheffield, S10 2TH
University Hospital Southampton
Southampton, SO16 6YD
The Royal Marsden Hospital
Sutton, SM2 5PT
Belgium1 site
Cliniques Universitaires Saint-Luc
Brussels, Woluwe-Saint-Lambert, 1200
About this study
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.
Read the detailed description
The trial will evaluate whether reducing treatment for low risk HB patients maintains their excellent event free survival (EFS) and decreases acute and long-term toxicity. Intensification of therapy with the use of novel agents will be evaluated in the high risk group. The trial will also compare three different regimens in intermediate risk HB.
Patients with HCC will be divided into groups based on whether the tumour is resectable or unresectable and/or metastatic.
Evaluation of the biology of HB and HCC, using the identification/validation of novel and already reported prognostic biomarkers as well as toxicity biomarkers is a key strand of this trial, so patients in all risk groups can be registered. The trial is also designed to optimise the collection of clinically annotated biologic specimens and establish the world's largest repository of blood and tissue samples from paediatric patients with HB and HCC.
The trial includes 4 randomised comparisons addressing therapeutic questions. For low risk HB patients, outcome with a total of 4 cycles of treatment is not inferior to those receiving a total of 6 cycles of treatment.
For intermediate risk patients, 3 regimens will be compared for outcome and toxicity.
For high risk patients, 2 post induction regimens will be compared for outcome. For resected HCC patients, the addition of GEMOX to PLADO regimen will be compared.
In addition the following will be assessed:
- To validate a new global risk stratification, defined by Children's Hepatic Tumours International Collaboration (CHIC)
- To evaluate clinically relevant factors, including the following:
- Provide a comprehensive and highly-validated panel of diagnostic and prognostic biomarkers
- Determine if paediatric HCC is a biologically different entity to adult HCC
- Develop genomic and/or biomarker analysis to predict children who may have an increased risk of developing toxicity with chemotherapy.
- To establish a collection of clinically and pathologically-annotated biological samples.
- Evaluate a surgical planning tool for an impact on decision making processes in POST-TEXT III and IV HB
- Conditions
- Hepatoblastoma, Carcinoma, Hepatocellular
- Being tested
- Cisplatin, Doxorubicin, Carboplatin, 5Fluorouracil, Vincristine
- Medical subject headings
- Hepatoblastoma, Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CisplatinDrug
Arms A and B - cisplatin is used alone Arms C, D, E and F - cisplatin us used in combination
DoxorubicinDrug
Arms C, D and E used in combination
CarboplatinDrug
Arms C and D used in combination
5FluorouracilDrug
Arm C used alone
VincristineDrug
Arms C and D used in combination
EtoposideDrug
Arm D used in combination
IrinotecanDrug
Arm D used in combination
GemcitabineDrug
Arm F used in combination
OxaliplatinDrug
Arm F used in combination
SorafenibDrug
Arm used in combination
| Study group | Role | What they receive |
|---|---|---|
| Group A Very Low Risk HB | Other | Patients with well differentiated foetal histology will receive 2 cycles of Cisplatin (2x 100mg/m2). Patients will non-well differentiated histology will be followed up only (no intervention). Receives: Drug: Cisplatin |
| Group B Low Risk HB | Active comparator | Patients who are resected after 2 cycles of Cisplatin will be randomised to receive 4 or 6 cycles of Cisplatin overall (80mg/m2). Patients who are not resected will continue to receive up to 6 cycles of Cisplatin (80mg/m2) until resection. Receives: Drug: Cisplatin |
| Group C Intermediate Risk HB | Active comparator | Patients 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) Receives: Drug: Cisplatin; Drug: Doxorubicin; Drug: Carboplatin; Drug: 5Fluorouracil; Drug: Vincristine |
| Group D High Risk HB | Active comparator | Patients 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). Receives: Drug: Cisplatin; Drug: Doxorubicin; Drug: Carboplatin; Drug: Vincristine; Drug: Etoposide; Drug: Irinotecan |
| Group E Resected HCC | Other | 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. Receives: Drug: Cisplatin; Drug: Doxorubicin |
| Group F Unresected HCC | Active comparator | Patients 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) Receives: Drug: Cisplatin; Drug: Doxorubicin; Drug: Gemcitabine; Drug: Oxaliplatin; Drug: Sorafenib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Event-free survival (EFS)
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.
Measured: 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
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.
Measured: From date of screening assessment until date of first response assessment, up to 63 days in Group F
Secondary outcomes (8)
Failure-free survival (FFS)
Failure-free survival (FFS) 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. failure to go to resection.
Measured: From date of randomisation (or registration into the trial for non-randomised patients) until date of first failure event, or date of last follow up assessment, assessed up to 6 years.
Overall survival (OS)
Overall survival (OS) is defined as the time from randomisation (or registration for non-randomised patients) to death from any cause. Patients who have not died will be censored at their last follow-up date.
Measured: From date of randomisation (or registration for non-randomised patients) until date of death from any cause, or date of last follow up assessment, assessed up to 6 years.
Toxicity categorized and graded using Common Terminology Criteria for Adverse Events (CTCAE)
Toxicity will be recorded in relation to each cycle of randomised treatment and will be categorized and graded using Common Terminology Criteria for Adverse Events (CTCAE)
Measured: From date of start of randomised treatment until date 30 days after last treatment.
Chemotherapy-related cardiac, nephro- and oto-toxicity using Common Terminology Criteria for Adverse Events (CTCAE)
Chemotherapy-related cardiac, nephro- and oto-toxicity will be recorded in relation to each cycle of treatment and will be categorized and graded using Common Terminology Criteria for Adverse Events (CTCAE)
Measured: From date of start of randomised treatment until date 30 days after last treatment.
Hearing loss according to the SIOP Boston Scale
Hearing loss will be measured according to the SIOP Boston Scale for oto-toxicity. The assessment will be performed at end of treatment (EOT) and follow up
Measured: From date of registration until date of last follow up assessment, or date of death, assessed up to 6 years.
Best Response
Best Response is defined as CR or PR and is based on radiological response (RECIST v1.1) and Alpha Fetoprotein (AFP) decline. Best Response will be measured throughout treatment period. Patients who are not assessable for response - e.g. because of early stopping of treatment or death - will be assumed to be non-responders.
Measured: From date of first treatment until the date of last treatment, or until the date of first documented progression or date of death, assessed up to 6 months.
Surgical resectability defined as complete resection, partial resection or transplant
Surgical resectability is defined as complete resection, partial resection or transplant
Measured: From date of registration until date of last follow up assessment, or date of death, assessed up to 6 years.
Adherence to surgical guidelines
Adherence to surgical guidelines is defined as the local clinician's surgical decision to resect or not compared to the current SIOPEL surgical guidelines.
Measured: From date of registration until date of last follow up assessment, or date of death, assessed up to 6 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2017 (estimated)
- Study start24 Aug 2017
- Primary completion31 Dec 2026 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HepatoblastomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- Fundació Institut Germans Trias i Pujol, University Hospital Munich, University Hospital, Bonn, University of Kiel, University Hospital Tuebingen, University of Padova, Ludwig-Maximilians - University of Munich, Medical University of Gdansk, Cliniques universitaires Saint-Luc- Université Catholique de Louvain, Motol University Hospital, Rennes University Hospital, Children's University Hospital, Ireland, University of Oslo, Princess Maxima Center for Pediatric Oncology, Andaluz Health Service, Swiss Pediatric Oncology Group, Gothia Forum - Center for Clinical Trial, The Leeds Teaching Hospitals NHS Trust, Bambino Gesù Hospital and Research Institute, Newcastle University, Experimental Cancer Medicine Centres, XenTech, Evry
- Responsible party
- Sponsor
- Investigators
- Madhumita Dandapani, MD PhD, Principal investigator, University of NottinghamMarc Ansari, MD, Principal investigator, University of Geneva, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03017326
- Sponsor's protocol ID
- RG_15-114
- Acronym
- PHITT
- Status last verified
- May 2026
- First submitted
- 14 Dec 2016
- Last updated
- 13 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Paediatric Hepatic International Tumour Trial
- ClinicalTrials.gov ID
- NCT03017326
- Acronym / sponsor ID
- PHITT / RG_15-114
- Conditions
- Hepatoblastoma, Carcinoma, Hepatocellular
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- University of BirminghamUniversity, hospital or other
- Collaborators
- Fundació Institut Germans Trias i Pujol, University Hospital Munich, University Hospital, Bonn, University of Kiel, University Hospital Tuebingen, University of Padova, Ludwig-Maximilians - University of Munich, Medical University of Gdansk, Cliniques universitaires Saint-Luc- Université Catholique de Louvain, Motol University Hospital, Rennes University Hospital, Children's University Hospital, Ireland, University of Oslo, Princess Maxima Center for Pediatric Oncology, Andaluz Health Service, Swiss Pediatric Oncology Group, Gothia Forum - Center for Clinical Trial, The Leeds Teaching Hospitals NHS Trust, Bambino Gesù Hospital and Research Institute, Newcastle University, Experimental Cancer Medicine Centres, XenTech, Evry
- Study start
- 24 Aug 2017 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 11 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The trial will evaluate whether reducing treatment for low risk HB patients maintains their excellent event free survival (EFS) and decreases acute and long-term toxicity. Intensification of therapy with the use of novel agents will be evaluated in the high risk group. The trial will also compare three different regimens in intermediate risk HB.
Patients with HCC will be divided into groups based on whether the tumour is resectable or unresectable and/or metastatic.
Evaluation of the biology of HB and HCC, using the identification/validation of novel and already reported prognostic biomarkers as well as toxicity biomarkers is a key strand of this trial, so patients in all risk groups can be registered. The trial is also designed to optimise the collection of clinically annotated biologic specimens and establish the world's largest repository of blood and tissue samples from paediatric patients with HB and HCC.
The trial includes 4 randomised comparisons addressing therapeutic questions. For low risk HB patients, outcome with a total of 4 cycles of treatment is not inferior to those receiving a total of 6 cycles of treatment.
For intermediate risk patients, 3 regimens will be compared for outcome and toxicity.
For high risk patients, 2 post induction regimens will be compared for outcome. For resected HCC patients, the addition of GEMOX to PLADO regimen will be compared.
In addition the following will be assessed:
- To validate a new global risk stratification, defined by Children's Hepatic Tumours International Collaboration (CHIC)
- To evaluate clinically relevant factors, including the following:
- Provide a comprehensive and highly-validated panel of diagnostic and prognostic biomarkers
- Determine if paediatric HCC is a biologically different entity to adult HCC
- Develop genomic and/or biomarker analysis to predict children who may have an increased risk of developing toxicity with chemotherapy.
- To establish a collection of clinically and pathologically-annotated biological samples.
- Evaluate a surgical planning tool for an impact on decision making processes in POST-TEXT III and IV HB
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Group A Very Low Risk HB | Other | Drug: CisplatinPatients with well differentiated foetal histology will receive 2 cycles of Cisplatin (2x 100mg/m2). Patients will non-well differentiated histology will be followed up only (no intervention). |
| Group B Low Risk HB | Active comparator | Drug: CisplatinPatients who are resected after 2 cycles of Cisplatin will be randomised to receive 4 or 6 cycles of Cisplatin overall (80mg/m2). Patients who are not resected will continue to receive up to 6 cycles of Cisplatin (80mg/m2) until resection. |
| Group C Intermediate Risk HB | Active comparator | Drug: Cisplatin, Drug: Doxorubicin, Drug: Carboplatin, Drug: 5Fluorouracil, Drug: VincristinePatients 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 High Risk HB | Active comparator | Drug: Cisplatin, Drug: Doxorubicin, Drug: Carboplatin, Drug: Vincristine, Drug: Etoposide, Drug: IrinotecanPatients 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 Resected HCC | Other | Drug: Cisplatin, Drug: DoxorubicinPatients 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 Unresected HCC | Active comparator | Drug: Cisplatin, Drug: Doxorubicin, Drug: Gemcitabine, Drug: Oxaliplatin, Drug: SorafenibPatients 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) |
Who may qualify
- Ages
- Up to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- Clinical diagnosis of HB* and histologically defined diagnosis of HB or HCC.
- Age ≤30 years
- Written informed consent for trial entry
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CisplatinArms A and B - cisplatin is used alone Arms C, D, E and F - cisplatin us used in combination | Drug | Group A Very Low Risk HB, Group B Low Risk HB, Group C Intermediate Risk HB, Group D High Risk HB, Group E Resected HCC, Group F Unresected HCC |
| DoxorubicinArms C, D and E used in combination | Drug | Group C Intermediate Risk HB, Group D High Risk HB, Group E Resected HCC, Group F Unresected HCC |
| CarboplatinArms C and D used in combination | Drug | Group C Intermediate Risk HB, Group D High Risk HB |
| 5FluorouracilArm C used alone | Drug | Group C Intermediate Risk HB |
| VincristineArms C and D used in combination | Drug | Group C Intermediate Risk HB, Group D High Risk HB |
| EtoposideArm D used in combination | Drug | Group D High Risk HB |
| IrinotecanArm D used in combination | Drug | Group D High Risk HB |
| GemcitabineArm F used in combination | Drug | Group F Unresected HCC |
| OxaliplatinArm F used in combination | Drug | Group F Unresected HCC |
| SorafenibArm used in combination | Drug | Group F Unresected HCC |
Primary outcome
Event-free survival (EFS)
Time frame: 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
Time frame: 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.
8 secondary outcomes
Failure-free survival (FFS)
Time frame: From date of randomisation (or registration into the trial for non-randomised patients) until date of first failure event, or date of last follow up assessment, assessed up to 6 years.
Overall survival (OS)
Time frame: From date of randomisation (or registration for non-randomised patients) until date of death from any cause, or date of last follow up assessment, assessed up to 6 years.
Toxicity categorized and graded using Common Terminology Criteria for Adverse Events (CTCAE)
Time frame: From date of start of randomised treatment until date 30 days after last treatment.
Chemotherapy-related cardiac, nephro- and oto-toxicity using Common Terminology Criteria for Adverse Events (CTCAE)
Time frame: From date of start of randomised treatment until date 30 days after last treatment.
Hearing loss according to the SIOP Boston Scale
Time frame: From date of registration until date of last follow up assessment, or date of death, assessed up to 6 years.
Best Response
Time frame: From date of first treatment until the date of last treatment, or until the date of first documented progression or date of death, assessed up to 6 months.
Surgical resectability defined as complete resection, partial resection or transplant
Time frame: From date of registration until date of last follow up assessment, or date of death, assessed up to 6 years.
Adherence to surgical guidelines
Time frame: From date of registration until date of last follow up assessment, or date of death, assessed up to 6 years.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Madhumita Dandapani, MD PhD principal investigator
University of Nottingham
Marc Ansari, MD principal investigator
University of Geneva, Switzerland
32 sites in 14 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Cisplatin, Doxorubicin and Carboplatin in people with Hepatoblastoma and Carcinoma, Hepatocellular, run by University of Birmingham at 32 sites in 14 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 13 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 32 sites in United Kingdom, Austria, Belgium, Czechia, Finland and 9 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Event-free survival (EFS) (time frame: From date of randomisation (or registration into the trial for non-randomised patients), until date of first failure event, assessed up to 6 years.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2026.