Treatment for children with newly diagnosed hepatoblastoma using a modified strategy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 3 multi-institutional study aims to treat children with newly diagnosed hepatoblastoma by evaluating the efficacy of sodium thiosulfate (STS) to protect against hearing impairment caused by cisplatin therapy in non-metastatic patients. It also assesses the event-free survival of patients with metastatic disease receiving a specific induction therapy followed by tailored consolidation therapy. The study includes various groups based on the disease's characteristics and treatment responses, with a focus on optimizing outcomes for both localized and metastatic hepatoblastoma. Additionally, it explores the feasibility of surgical resection after specific chemotherapy regimens.

Why it matters

Who can join: the full rules

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 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 Criteria:

* 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's running

• Shanghai Children's Medical Center
  Shanghai, Shanghai Municipality, China Recruiting

Study contacts

• Principal investigator: Yi-Jin Gao, MD — Shanghai Children's Medical Center
• Study coordinator: Haishan Ruan, MS
• Email: ruanhaishan@scmc.com.cn
• Phone: +8618801902467

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.