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Paediatric Hepatic International Tumour Trial

Paediatric Hepatic International Tumour Trial

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1800018774
Enrollment
Unknown
Registered
2018-10-09
Start date
2018-10-15
Completion date
Unknown
Last updated
2018-10-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Paediatric hepatic tumour

Interventions

Group A – Very Low Risk HB A1:No further treatment
Group A – Very Low Risk HB A2:2 cycles cisplatin
Group B - Low Risk HB Patients B1:2 cycles cisplatin vs 4 cycles cisplatin
Group B - Low Risk HB Patients B2:resected after 2 cycles cispltin and 2 cycles cisplatin following
Group C - Intermediat e Risk HB Patients:SIOPEL-3HR vs C5VD vs CDDP-M
Group D - High Risk HB Patients D1:Arm A-CD
Group D - High Risk HB Patients D2:CD alternating with CE
Group D - High Risk HB Patients D3:CD alternating with VI
Group E - Resected HCC Patients E1:No further treatment
Group E - Resected HCC Patients E2:denovo HCC OLADO
Group F - Not Resected HCC Patients E1:PALDO+S vs PALDO + S/GEMOX + S

Sponsors

Guangzhou Woman and Children's Medical Center
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Clinical diagnosis of HB* and histologically defined diagnosis of HB or HCC. Histological confirmation of HB is required except in emergency situations where: 1. the patient meets all other eligibility criteria, but is too ill to undergo a biopsy safely, the patient may be enrolled without a biopsy; 2. there is anatomic or mechanical compromise of critical organ function by tumour(e.g., respiratory distress/failure, abdominal compartment syndrome, urinary obstruction, etc.); 3. Uncorrectable coagulopathy 4. Aged =30 years; 5. Written informed consent for trial entry.

Exclusion criteria

Exclusion criteria: 1. Any previous chemotherapy or currently receiving anti-cancer agents; 2. Recurrent disease; 3. Previously received a solid organ transplant; other than orthotopic liver transplantation (OLT); 4. Uncontrolled infection; 5. Unable to follow or comply with the protocol for any reason; 6. Second malignancy; 7. Pregnant or breastfeeding women.

Design outcomes

Secondary

MeasureTime frame
Response in HCC;Best Response;Surgical resectability;Adherence to surgical guidelines;

Primary

MeasureTime frame
EFS;OS;FFS;Toxicity;

Countries

China

Contacts

Public ContactYan Zou

Guangzhou Woman and Children's Medical Center

monknut@126.com+86 13632330589

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026