SIOPEL 5 (HCC-1) trial on the hepatocellular carcinoma family of tumours in children/adolescents and young adults - SIOPEL 5

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2005-000427-42-GB

Enrollment

Registered

2005-03-22

Start date

2005-04-15

Completion date

Unknown

Last updated

2020-07-27

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

Conditions

Hepatocellular carcinoma

Interventions

Trade Name: Cyclophosphamide Tablet 50mg Pharmaceutical Form: Tablet Concentration unit: mg/g milligram(s)/gram Concentration type: equal Concentration number: 50- Trade Name: Cisplatin Pharmaceutica

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Newly diagnosed non-cirrhotic hepatocellular carcinomasq =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Patients unable to follow the protocol for any reason Patients referred for recurrent disease Positive pregnancy test Patients with life expectancy below 3 months Abnormal renal function at diagnosis as GFR <75-50% of the lower limit of normal for age which over 2 years of age is <60ml/min/1.73m2 Cardiac EF <29% at baseline echo

Design outcomes

Primary

Measure	Time frame
Main Objective: To achieve complete remission of tumour by the application of preoperative chemotherapy, surgery and chemoembolisation;Secondary Objective: To determine response rates to preoperative chemotherapy with the addition of anti-angiogenic (thalidomide) therapyTo determine long term remission status with the use of metronomic oral cyclophosphamide and thalidomide post resectionTo determine the toxicity of the addition of thalidomide to conventional chemotherapy;Primary end point(s): Complete remission status	—

Measure

Time frame

Main Objective: To achieve complete remission of tumour by the application of preoperative chemotherapy, surgery and chemoembolisation;Secondary Objective: To determine response rates to preoperative chemotherapy with the addition of anti-angiogenic (thalidomide) therapyTo determine long term remission status with the use of metronomic oral cyclophosphamide and thalidomide post resectionTo determine the toxicity of the addition of thalidomide to conventional chemotherapy;Primary end point(s): Complete remission status

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Countries

United Kingdom

Outcome results

None listed

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