Actively Recruiting
A Multi-institutional Study for Treatment of Children With Newly Diagnosed Hepatoblastoma Using a Modified PHITT Strategy
Led by Shanghai Children's Medical Center · Updated on 2026-05-04
330
Participants Needed
1
Research Sites
343 weeks
Total Duration
On this page
Sponsors
S
Shanghai Children's Medical Center
Lead Sponsor
S
Shanghai Children's Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
A Multi-institutional Study for Treatment of Children With Newly Diagnosed Hepatoblastoma Using a Modified PHITT Strategy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients must have a performance status of ECOG 0, 1, or 2 (Karnofsky for >16 years, Lansky for 616 years).
- Newly diagnosed with histologically confirmed primary pediatric hepatoblastoma.
- Patients too ill for biopsy in emergencies may be enrolled if other criteria are met.
- Prior surgical removal of liver tumor is allowed; no other prior anti-cancer therapy for current lesion.
- Adequate kidney function with creatinine clearance or GFR 65 70 mL/min/1.73 m2.
- Adequate liver function with total bilirubin 64 5 times upper normal limit and AST or ALT <10 times upper normal limit for age.
- Adequate lung function if clinically indicated (normal pulmonary function tests).
You will not qualify if you...
- Prior chemotherapy or tumor-directed therapy other than surgery (e.g., radiation, biologics, local therapies).
- Current use of another investigational drug.
- Current use of other anticancer agents.
- Uncontrolled infections.
- Previous solid organ transplant.
AI-Screening
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Trial Site Locations
Total: 1 location
1
Shanghai Children's Medical Center
Shanghai, Shanghai Municipality, China, 200127
Actively Recruiting
Research Team
H
Haishan Ruan, MS
CONTACT
Y
Yujia Tang, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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