NCT04478292 A Multi-institutional Study for Treatment of Children With Newly Diagnosed Hepatoblastoma Using a Modified PHITT Strategy
| NCT ID | NCT04478292 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Shanghai Children's Medical Center |
| Condition | Hepatoblastoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 330 participants |
| Start Date | 2021-03-01 |
| Primary Completion | 2027-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 330 participants in total. It began in 2021-03-01 with a primary completion date of 2027-03-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 randomized assessment of sodium thiosulfate as auditory protection for children with localized disease, and response adapted therapy for patients with metastatic disease
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 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.
Contact & Investigator
Yi-Jin Gao, MD
PRINCIPAL INVESTIGATOR
Shanghai Children's Medical Center
Frequently Asked Questions
Who can join the NCT04478292 clinical trial?
This trial is open to participants of all sexes, up to 18 Years, studying Hepatoblastoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04478292 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 330 participants.
Is NCT04478292 currently recruiting?
Yes, NCT04478292 is actively recruiting participants. Contact the research team at ruanhaishan@scmc.com.cn for enrollment information.
Where is the NCT04478292 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT04478292 clinical trial?
NCT04478292 is sponsored by Shanghai Children's Medical Center. The principal investigator is Yi-Jin Gao, MD at Shanghai Children's Medical Center. The trial plans to enroll 330 participants.