Treatment of advanced hepatocellular carcinoma (HCC) with portal vein thrombosis by hepatic intra-arterial injection of microspheres loaded with Yttrium-90 (Thera-Sphere) - RAD-09

• Conditions: advanced hepatocellular carcinoma (HCC) with portal vein thrombosis; MedDRA version: 9.1Level: LLTClassification code 10024662; MedDRA version: 9.1Level: PTClassification code 10019713

• Registration Number: EUCTR2009-016475-29-IT
• Lead Sponsor: AZIENDA OSPEDALIERA DI BOLOGNA POLICLINICO S. ORSOLA M. MALPIGHI

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-03-23
• Last Update Posted: 24 February 2014

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Diagnosis of HCC: based on the Guidelines issued by EASL and AASLD criteria (latest diagnostic radiological imaging performed within 1 month from enrollment) 2. HCC for which transplantation, surgical resection or percutaneous ablation are not indicated 3. Portal vein thrombosis (segmental or lobar branch and common portal trunk) 4. Tumor volume  50% of whole liver 5. Child-Pugh class A-B7 6. Performance status: ECOG 0-2 (WHO) 7. Target liver lesion measurable 8. Life expectancy of at least 3 months in absence of treatments 9. The following laboratory parameters must be met: Creatinine ≤ 1.50 mg/dL Bilirubin  2 mg/dL Albumin  3 g/dL White blood cells 1.5 x 109/L PLT  50 x 109/L PT  50% 10. Signature of informed consent obtained
Are the trial subjects under 18? no
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) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Liver tumor undefined, unmeasurable or not assessable 2. Uncontrolled ascites, F3-type varices 3. Contraindications to arteriography 4. Presence of hemodynamically relevant abnormalities of hepatic arterial structure, such as not to allow for a correct and safe delivery of microspheres 5. Presence of hepato-pulmonary shunt percentage potentially for >30 Gy exposure to lungs 6. Presence of chronic or acute co-morbidities (to lungs, heart, kidneys or brain) because of which the patient is not eligible to receive the treatment foreseen by the protocol. 7. Prior tumors in the 5 preceding years or concomitance of other tumors at enrollment, with the exception of cutaneous basal cell or squamous cells carcinoma or carcinoma in situ of the uterine cervix 8. Presence of localized or systemic infections (with the exception of HIV infection responsive to therapy) 9. Pregnant women (women of child-bearing potential will have a pregnancy test done) and breastfeeding women 10. Age under 18 years 11. Known or suspect hypersensitivity to the investigational drug or to the investigational pharmacological class 12. Patients presenting with severe clinical conditions which in the opinion of the investigator contraindicate patient participation in the study 13. Use of investigational drugs in the last month prior to inclusion into the study 14. Patients who are not capable of complying with the procedures established by the protocol and of signing the informed consent.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: 1. radiological tumor response according to RECIST modified, WHO modified-EASL and Choi criteria and laboratory response (alpha-fetoprotein level).;Secondary Objective: 1. time to progression of disease in the liver and any other site (TTP) 2. time to symptomatic progression of disease (TTSP) assessed by FHSI-8 questionnaire 3. time to untreatable progression (TTUP) 4. toxicity assessed by CTCAE criteria 5. survival from the time of treatment with TheraSphere 6. quality of life assessed by FACT-Hep questionnaire;Primary end point(s): The primary endpoint of the study is to access: 1. radiological tumor response according to RECIST modified, WHO modified-EASL and Choi criteria and laboratory response (alpha-fetoprotein level).