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

AZIENDA OSPEDALIERA DI BOLOGNA POLICLINICO S. ORSOLA M. MALPIGHI0 sitesMarch 23, 2010

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: advanced hepatocellular carcinoma (HCC) with portal vein thrombosis
Sponsor: AZIENDA OSPEDALIERA DI BOLOGNA POLICLINICO S. ORSOLA M. MALPIGHI
Status: Active, not recruiting
Last Updated: 12 years ago

No summary available.

Registry

who.int

Start Date

March 23, 2010

End Date

TBD

Last Updated

12 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

AZIENDA OSPEDALIERA DI BOLOGNA POLICLINICO S. ORSOLA M. MALPIGHI

•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

•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.