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Study identifier: NCT07300449 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

A Prospective Multicenter Clinical Study of SCCG Protocol and ctDNA 5hmc in Predicting the Chemotherapy Sensitivity and Monitoring the Recurrence and Metastasis of Hepatoblastoma in Children and Adolescents

Condition: Hepatoblastoma  ·  Sponsor: Sun Yat-sen University

PhasePhase 2
Planned participants100
Who can joinAll sexes, N/A to 18 Years
Healthy volunteersNo

About this study

Hepatoblastoma is the most common malignant liver tumor in infants and preschool children, comprising 65% of pediatric liver malignancies in those under 15, with its incidence on the rise in recent years \[1\]. Standard therapy combines surgical resection and chemotherapy: early-stage patients boast a survival rate over 90%, yet high-risk cases only reach around 40%, highlighting unmet treatment needs. Notably, there is no universal definition for high-risk hepatoblastoma. The U.S. COG (AHEP0731) categorizes it as stage 4 disease, AFP \<100ng/ml at diagnosis (any stage), or small cell undifferentiated histology; conversely, SIOP includes factors like major vascular invasion (inferior vena cava/portal vein), intra-abdominal extrahepatic spread, distant metastasis, AFP \<100ng/ml, or tumor rupture, regardless of PRETEXT stage. To improve outcomes, international teams have tested intensified chemotherapy: Europe's SIOPEL reported that escalated cisplatin-doxorubicin regimens lifted high-risk patients' 3-year overall survival to over 80% \[2\], though with heightened toxicity. Similarly, Germany's IPA (ifosfamide-cisplatin-doxorubicin) and Japan's ITEC (ifosfamide-doxorubicin-carboplatin-VP-16) regimens delivered significant survival benefits but also amplified side effects \[3,4\]. Against this backdrop, the Guangdong Anti-Cancer Association's Pediatric Oncology Committee, led by Sun Yat-sen University Cancer Center and involving 15 hospitals, is launching a multicenter prospe…

This description comes directly from the study's public registry record.

Talk to the study team

Yizhuo Zhang, PhD  ·  02087342460  ·  wangjuan@sysucc.org.cn

Junting Huang, PhD  ·  02087342460  ·  huangjt@sysucc.org.cn

Always discuss trial participation with your own doctor first.

Locations (2)

Sun Yat-sen University Cancer CenterGuangzhou, Guangdong, ChinaRecruiting
Sun Yat-sen University Cancer CenterGuangzhou, Guangdong, ChinaRecruiting

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Source record: clinicaltrials.gov/study/NCT07300449