Radioembolization With Yttrium-90 Microspheres for Intermediate or Advanced HCC (Hepatocellular Carcinoma) Not Eligible to Curative Approach. A Phase II-b Study.
18 Years
80 Years
Both
Hepatocellular Carcinoma, Liver Cancer
Trial Information
Radioembolization With Yttrium-90 Microspheres for Intermediate or Advanced HCC (Hepatocellular Carcinoma) Not Eligible to Curative Approach. A Phase II-b Study.
Patients at an intermediate stage (BCLC-B) are currently offered trans-arterial
chemoembolisation (TACE) as the standard of care. A recent meta-analysis showed that
radioembolization with beta-emitting Yttrium-90-loaded glass microspheres (TheraSphere®) in
patients with HCC achieves a median objective response in 79% of cases (range 29-88%) and
median survival exceeding 15 months has been reported in patients at intermediate stages who
have been treated with TheraSphere®.
In patients with HCC at an advanced stage (BCLC-C) the single treatment that has shown a
statistical advantage on overall survival and disease progression is sorafenib, that
provides a median survival of 10.7 months. Based on the results reported in literature, the
estimated median expected survival of patients with advanced HCC treated by TheraSphere® can
be as long as 12 months.
After approval on July 2007 of a treatment protocol of Y-90 for compassionate use by the
institutional IRB, at the National Cancer Institute of Milan 40 consecutive patients have
been treated with radioembolization with Yttrium-90 microspheres (Theraspheres®) according
to the same guidelines of the present prospective phase II protocol. The initial series of
40 patients treated according to a compassionate use of Y-90 has been instrumental for the
assessment of the procedure's safety and tolerability. The present study has been targeted
to 60 cases including the fist series of 40 "compassionate" patients, due to their adherence
to the same inclusion/exclusion criteria of the proposed phase II study.
Inclusion Criteria:
1. Diagnosis of HCC confirmed by histology or non-invasive criteria (EASL/AASLD)
2. Intermediate stage (BCLC-B) HCC: patients with a large or multinodular HCC (single
HCC > 5 cm or multiple HCC defined as > 3 nodules > 3 cm), a Child Pugh class A or B7
and no cancer related symptoms (PS=0-1).
3. Advanced stage (BCLC-C) HCC: patients with hepatic vascular involvement (at any tumor
number and diameter), a Child Pugh class A or B7, no cancer related symptoms (PS=0-1)
and absence of extra-hepatic tumor spread.
4. Cancer-related symptoms within the ECOG 0-1 score
5. Liver function within Child B-7 class
6. Platelets > 50.000/µL
7. WBC > 1500/µL
8. AST/ALT < 5 times the upper limit of normal (U/L)
9. Creatinine < 2.0 mg /dL
10. No indication for any possible curative treatment after multidisciplinary assessment
(resection, ablation, transplantation)
11. Signed informed consent
Exclusion Criteria:
1. Child-Pugh class higher than B-7 at entry
2. ECOG performance score ≥ 2 at entry
3. Tumor volume ≥ 50% of liver volume
4. Extrahepatic tumor spread
5. Pulmonary insufficiency
6. Life expectancy of less than 3 months due to HCC or less than 6 months due to any
other disease
7. Previous chemoembolization procedure (TACE)
8. Evidence on 99mTc-MAA scan of vascular shunts that can not be corrected by
angiographic coil embolization
9. Evidence on 99mTc-MAA scan of lung shunting, with a potential absorbed dose of
radiation to the lungs > 30 Gy
Type of Study:
Interventional
Study Design:
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Time to progression (TTP)
Outcome Time Frame:
At 1, 3, 6, 12 months and every 6 months thereafter
Safety Issue:
No
Principal Investigator
Vincenzo Mazzaferro, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, Italy
Authority:
Italy: National Institute of Health
Study ID:
INT 30/90
NCT ID:
NCT00910572
Start Date:
July 2007
Completion Date:
May 2010
Related Keywords:
- Hepatocellular Carcinoma
- Liver Cancer
- Yttrium-90
- Radiation
- Radioembolization
- Hepatoma
- BCLC classification
- Hepatic loco-regional treatments
- Yttrium
- Microspheres
- Carcinoma
- Liver Neoplasms
- Carcinoma, Hepatocellular
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