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

Phase 1

• Conditions: Hepatocellular carcinoma

• Registration Number: EUCTR2005-000427-42-GB
• Lead Sponsor: K Children’s Cancer Study Group

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-03-22
• Last Update Posted: 27 July 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 47

Inclusion Criteria

Newly diagnosed non-cirrhotic hepatocellular carcinomasq
<30 years of age at the time of diagnosisq
No previous treatment for HCC
Appropriate diagnostic / staging imaging performed.
Confirmed diagnosis - hepatocellular carcinoma family” of tumours: includes fibrolamellar and transitional variants. (NB: percutaneous needle biopsy is mandatory, unless primary tumour resection is attempted)
Negative pregnancy test
Written informed consent and national/local ethical committee approval
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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