Clinical trial · Interventional
Paediatric Hepatic International Tumour Trial
NCT03017326CI-TRIAL-00111451PHITTactive not recruitingPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Carcinoma, Hepatocellular | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Hepatoblastoma | Hepatoblastoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (10)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 5Fluorouracil | Drug | — | UNRESOLVED |
| Carboplatin | Drug | Carboplatin | ALIAS |
| Cisplatin | Drug | Cisplatin | ALIAS |
| Doxorubicin | Drug | Doxorubicin | ALIAS |
| Etoposide | Drug | Etoposide | ALIAS |
| Gemcitabine | Drug | Gemcitabine | ALIAS |
| Irinotecan | Drug | Irinotecan | ALIAS |
| Oxaliplatin | Drug | Oxaliplatin | ALIAS |
| Sorafenib | Drug |
Design
Arms and outcomes
Arms (6)
- type
- OTHER
- label
- Group A Very Low Risk HB
- description
- 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).
- interventionNames
- Drug: Cisplatin
- type
- ACTIVE_COMPARATOR
- label
- Group B Low Risk HB
- description
- 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.
- interventionNames
- Drug: Cisplatin
- type
- ACTIVE_COMPARATOR
- label
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 30 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.