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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

RecruitingPhase 2Ages any - 18 YearsAllSun Yat-sen University
NCT07300449 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 intensifi

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📋 Eligibility rules (as published)
Inclusion Criteria: * Patients with primary hepatoblastoma confirmed by pathology. * The age of the subjects was less than 18 years old. ③ Obtain the informed consent from the guardians and sign the informed consent form Exclusion Criteria: * Recurrent hepatoblastoma or other malignant tumor. * Age\> 18 years old. ③ Patients with other tumors and received chemotherapy and abdominal radiotherapy. * Heart, brain and kidney failure patients.
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What it tests

  • Very low-risk group
  • Low-risk group
  • Intermediate-risk group
  • High-risk group
  • 5hmc dynamic monitoring
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Where

2 sites
Sun Yat-sen University Cancer Center
Guangzhou, China
Sun Yat-sen University Cancer Center
Guangzhou, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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