A Multi-institutional Study for Treatment of Children With Newly Diagnosed Hepatoblastoma Using a Modified PHITT Strategy

Recruiting Phase 3 Interventional Study
Hepatoblastoma
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
Up to 18
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
330 (estimated)
Sponsor
Shanghai Children's Medical Center · Other
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About This Trial

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

Trial Locations
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Eligibility Criteria
Inclusion Criteria: * 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 H…
Contacts

Haishan Ruan, MS

+8618801902467

ruanhaishan@scmc.com.cn

CONTACT

Yujia Tang, MD

+8618516342079

tangyuejia@scmc.com.cn

CONTACT