OncoMatch/Clinical Trials/NCT04478292
A Multi-institutional Study for Treatment of Children With Newly Diagnosed Hepatoblastoma Using a Modified PHITT Strategy
Is NCT04478292 recruiting? Yes, currently enrolling (Jun 2026). This Phase 3 trial studies multiple treatments for hepatoblastoma.
Treatment: Sodium Thiosulfate · mono CDDP-Group A2 · Cisplatin, 5-Fluorouracil, Vincristine, Doxorubicin-Group C · mono CDDP- Group B · Block 1 to 3 (Cisplatin, Doxorubicin) Group D · Consolidation (Carboplatin, Doxorubicin) -Group D1 · Consolidation (Carboplatin +Doxorubicin/Vincristine + Irinotecan)-Group D2 — A Phase 3 multi-institutional study for treatment of children with newly diagnosed hepatoblastoma using a modified Paediatric Hepatic International Tumour Trial (PHITT) strategy incorporating a randomized assessment of sodium thiosulfate as auditory protection for children with localized disease, and response adapted therapy for patients with metastatic disease
Check if I qualifyExtracted eligibility criteria
Treatments studied
Chemotherapy
Other
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Demographics
Prior therapy
Must have received: surgical resection — hepatic malignancy
Patients may have had surgical resection of the hepatic malignancy prior to enrollment
Cannot have received: chemotherapy
Prior chemotherapy or tumor directed therapy expect for surgical resection of the hepatic malignancy
Cannot have received: radiation therapy
Prior chemotherapy or tumor directed therapy expect for surgical resection of the hepatic malignancy (i.e. radiation therapy, biologic agents, local therapy (embolization, radiofrequency ablation, and laser))
Cannot have received: biologic agent
Prior chemotherapy or tumor directed therapy expect for surgical resection of the hepatic malignancy (i.e. radiation therapy, biologic agents, local therapy (embolization, radiofrequency ablation, and laser))
Cannot have received: local therapy (embolization, radiofrequency ablation, laser)
Prior chemotherapy or tumor directed therapy expect for surgical resection of the hepatic malignancy (i.e. radiation therapy, biologic agents, local therapy (embolization, radiofrequency ablation, and laser))
Lab requirements
Kidney function
Creatinine clearance or radioisotope GFR ≥ 70 mL/min/1.73 m2
Liver function
Total bilirubin ≤ 5 x upper limit of normal (ULN) for age, and AST or ALT < 10 x ULN for age
Adequate renal function defined as: Creatinine clearance or radioisotope Glomerular Filtration Rate (GFR) ≥ 70 mL/min/1.73 m2; Adequate liver function defined as: Total bilirubin ≤ 5 x upper limit of normal (ULN) for age, and AST or ALT < 10 x ULN for age; Adequate pulmonary function defined as: Normal pulmonary function tests (including DLCO) if there is clinical indication for determination (e.g. dyspnea at rest, known requirement for supplemental oxygen)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT04478292 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
Is there an age limit?
Yes. Patients must be 18 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify