NCT04478292 is a Phase 3 clinical trial of Sodium Thiosulfate Injection in Hepatoblastoma, sponsored by Shanghai Children's Medical Center.

Who is sponsoring NCT04478292?

NCT04478292 is sponsored by Shanghai Children's Medical Center.

What drugs are being tested in NCT04478292?

Interventions in NCT04478292: Sodium Thiosulfate Injection, Primary surgery resection, mono CDDP-Group A2, Cisplatin, 5-Fluorouracil, Vincristine, Doxorubicin-Group C, Biopsy, Resection or transplant, Resection of pulmonary nodules, mono CDDP- Group B, Block 1 to 3 (Cisplatin, Doxorubicin) Group D, Consolidation (Carboplatin, Doxorubicin) -Group D1, Consolidation (Carboplatin +Doxorubicin/Vincristine + Irinotecan)-Group D2.

What condition does NCT04478292 study?

NCT04478292 studies Hepatoblastoma.

Is NCT04478292 still recruiting?

NCT04478292 is currently recruiting now. Last updated 18 May 2025.

Last reviewed 2025-05-18 · How we verify

NCT04478292

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Recruiting now Phase 3 Last updated 18 May 2025

What this trial tests

Phase 3 trial testing Sodium Thiosulfate Injection in Hepatoblastoma in 330 participants. Currently enrolling.

Timeline

1 March 2021

Primary endpoint
31 March 2026

30 September 2027

Quick facts

Lead sponsor	Shanghai Children's Medical Center
Phase	Phase 3
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	330
Start date	1 March 2021
Primary completion	31 March 2026
Estimated completion	30 September 2027
Sites	1 location across China

Drugs / interventions tested

Sodium Thiosulfate Injection
Primary surgery resection
mono CDDP-Group A2 — full drug profile →
Cisplatin, 5-Fluorouracil, Vincristine, Doxorubicin-Group C
Biopsy
Resection or transplant
Resection of pulmonary nodules
mono CDDP- Group B — full drug profile →
Block 1 to 3 (Cisplatin, Doxorubicin) Group D — full drug profile →
Consolidation (Carboplatin, Doxorubicin) -Group D1 — full drug profile →
Consolidation (Carboplatin +Doxorubicin/Vincristine + Irinotecan)-Group D2 — full drug profile →

Conditions studied

Hepatoblastoma — all drugs for Hepatoblastoma →

Sponsor

Shanghai Children's Medical Center

Who can join

Under 18, any sex, with Hepatoblastoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

Pharmacological Approaches to Hearing Loss.
Cederroth CR, Dyhrfjeld-Johnsen J, Canlon B. · · 2024 · cited 7× · PMID 39164117 · DOI 10.1124/pharmrev.124.001195
[Preliminary efficacy and safety of a dose-intensified C5VD regimen in 24 children with locally advanced hepatoblastoma].
Peng JX, Huang C, Zhang AA, Han YL, et al · · 2025 · PMID 41121702 · DOI 10.7499/j.issn.1008-8830.2502113

Verify or expand the search:

Other recruiting trials for Hepatoblastoma

Currently open trials in the same condition.

NCT07148050 — Immunotherapy for Solid Tumor Malignancies in Pediatrics Using Interleukin-15 and -21 Armored Glypican-3-specific Chimer · Phase 1 · recruiting
NCT06198296 — Immunotherapy For Adults With GPC3-Positive Solid Tumors Using IL-15 and IL-21 Armored GPC3-CAR T Cells · Phase 1 · recruiting
NCT07188311 — Pucotenlimab Combined With Lenvatinib and Chemotherapy in the Treatment of Advanced, Relapsed/Refractory Hepatoblastoma · NA · recruiting
NCT06521567 — A Study of Cobolimab Plus Dostarlimab in Pediatric and Young Adult Participants With Cancer · Phase 1, PHASE2 · active not recruiting
NCT04634357 — ET140203 T Cells in Pediatric Subjects With Hepatoblastoma, HCN-NOS, or Hepatocellular Carcinoma · Phase 1, PHASE2 · recruiting

Other Shanghai Children's Medical Center trials

Trials by the same sponsor.

NCT07383883 — Multimodal Tongue-Pulse Information Fusion for Syndrome Diagnosis and Cohort Study in Children With Asthma · recruiting
NCT07035821 — Olanzapine for Prevention of Vomiting in Children and Adolescents Receiving Highly Emetogenic Chemotherapy · Phase 3 · not yet recruiting
NCT07003126 — A Cohort Study on Treating Primary Nocturnal Enuresis by Regulating Central-Peripheral Circadian Rhythm · NA · not yet recruiting
NCT07351955 — Clinical Study on a Novel Strategy of Individualized Non-Invasive Neuromodulation for the Treatment of Tic Disorders in · NA · recruiting
NCT07000656 — Micturition Desire-Relaxation Training Device for Lower Urinary Tract Dysfunction in Children · NA · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04478292 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Shanghai Children's Medical Center
Last refreshed: 18 May 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04478292.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing