Status:
RECRUITING
A Multi-institutional Study for Treatment of Children With Newly Diagnosed Hepatoblastoma Using a Modified PHITT Strategy
Lead Sponsor:
Shanghai Children's Medical Center
Collaborating Sponsors:
Shanghai Children's Hospital
Conditions:
Hepatoblastoma
Eligibility:
All Genders
Up to 18 years
Phase:
PHASE3
Brief Summary
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 random...
Detailed Description
Primary aims: 1. Localized Disease: Groups B and C: To evaluate and validate the efficacy of sodium thiosulfate (STS) to reduce the hearing impairment caused by a cisplatin monotherapy in non-metasta...
Eligibility Criteria
Inclusion
- 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)
Exclusion
- 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.
Key Trial Info
Start Date :
March 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2027
Estimated Enrollment :
330 Patients enrolled
Trial Details
Trial ID
NCT04478292
Start Date
March 1 2021
End Date
September 30 2027
Last Update
May 18 2025
Active Locations (1)
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1
Shanghai Children's Medical Center
Shanghai, Shanghai Municipality, China, 200127