Using blood DNA 5hmC markers and the SCCG chemotherapy protocol to predict response and monitor relapse in children with hepatoblastoma
Official title: A Prospective Multicenter Clinical Study of the South China Collaborative Group Protocol for the Treatment of Hepatoblastoma in Children and Adolescents
Run by Sun Yat-sen University · NCT07300449 · Data updated 2026-11-12
This trial will test whether a blood-based DNA marker (5hmC) together with the SCCG treatment plan can predict chemotherapy response and detect recurrence in children and adolescents with hepatoblastoma.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | Any age to 18 Years |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | Sun Yat-sen University Academic / other |
| Drugs / interventions | chemotherapy, doxorubicin |
| Locations | 2 sites (Guangzhou, Guangdong and 1 other locations) |
| Status | Recruiting |
| Started | June 23, 2021 |
| Main results expected | December 30, 2027 |
| Study ends | December 31, 2028 |
| Registry record updated | December 23, 2025 |
| Trial ID | NCT07300449 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Children and adolescents under 18 with newly diagnosed, pathologically confirmed hepatoblastoma who have not received prior chemotherapy or abdominal radiotherapy and whose guardians provide informed consent.
✕Probably not a fit
Patients with recurrent hepatoblastoma, other active malignancies, prior systemic therapy or abdominal radiotherapy, or severe heart/brain/kidney failure are excluded and unlikely to benefit from this protocol.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a prospective multicenter Phase 2 effort led by Sun Yat-sen University Cancer Center that groups newly diagnosed pediatric hepatoblastoma patients into very low, low, intermediate, and high-risk treatment arms under the SCCG protocol. Investigators will collect serial plasma samples and use Nano-5hmC-Seal cfDNA profiling to measure 5hmC patterns (ctDNA) before, during, and after therapy. The trial aims to see if 5hmC signatures predict chemotherapy sensitivity and provide early warning of recurrence or metastasis. Patients under 18 with pathologically confirmed primary hepatoblastoma and guardian consent are eligible, while recurrent disease, other malignancies, prior chemo/radiation, or major organ failure are excluded.
Why it matters
Potential benefit: If successful, this approach could let clinicians tailor chemotherapy intensity and detect relapse earlier, potentially improving survival and reducing unnecessary toxicity.
How similar studies have gone: Early work with cfDNA 5hmC profiling has shown promising diagnostic and monitoring signals in other cancers and preliminary liver-tumor data, but applying it to predict chemo sensitivity in pediatric hepatoblastoma is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
-
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China Recruiting -
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China Recruiting
Study contacts
- Principal investigator: Junting Huang — SunYat Sen University Cancer Center
- Study coordinator: Yizhuo Zhang, PhD
- Email: wangjuan@sysucc.org.cn
- Phone: 02087342460
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.