A Multi-institutional Study for Treatment of Children With Newly Diagnosed Hepatoblastoma Using a Modified PHITT Strategy
Recruiting now · Phase 3
Conditions studied: Hepatoblastoma
In brief
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
Key facts
- Study ID
- NCT04478292
- Run by
- Shanghai Children's Medical Center
- People needed
- 330
- Starts
- 2021-03-01
- Expected to finish
- 2027-09-30
- Last updated by the study team
- 2026-05-04
Who can join
Age: any, up to 18. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Performance Level Patients must have a performance status corresponding to ECOG scores 0, 1, or 2. Use Karnofsky for patients >16 years of age and Lansky for patients ≤16 years of age.
- Diagnosis Patients must be newly diagnosed with histologically-proven primary pediatric HB
- Emergent Treatment for HB In emergency situation when a patient meets all other eligibility criteria and has had baseline required observations, but is too ill to undergo a biopsy safely, the patient may be enrolled without a biopsy.
- Prior Therapy Patients may have had surgical resection of the hepatic malignancy prior to enrollment. All other anti-cancer therapy for the current liver lesion is prohibited.
- Organ Function Requirements
- I) Adequate renal function defined as:
- Creatinine clearance or radioisotope Glomerular Filtration Rate (GFR) ≥ 70 mL/min/1.73 m2
- II) Adequate liver function defined as:
- Total bilirubin ≤ 5 x upper limit of normal (ULN) for age, and Aspartate aminotransferase (AST) or Alanine transaminase (ALT) < 10 x upper limit of normal (ULN) for age.
- III) 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)
You may not qualify if…
- 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)). Therefore, patients with a pre-disposition syndrome who have a prior malignancy are not eligible.
- Patients who are currently receiving another investigational drug.
- Patients who are currently receiving other anticancer agents.
- Patients with uncontrolled infection.
- Patients who previously received a solid organ transplant.
Where it is running
- Shanghai Children's Medical Center — Shanghai, Shanghai Municipality, China (enrolling)
Full record on ClinicalTrials.gov
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