Individualized dosimetry for holmium-166-radioembolization in patients with unresectable hepatocellular carcinoma; a multi-center, interventional, non-randomized, non-comparative, open label, early phase II study: iHEPAR

Recruiting

Conditions: hepatocellular carcinoma
primary liver cancer
10019815
10019818

Registration Number: NL-OMON55061

Lead Sponsor: niversitair Medisch Centrum Utrecht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 30

Inclusion Criteria

1. Patients must have given written informed consent.
2. Female or male aged 18 years and over.
3. Diagnosis of HCC established according to the Netherlands HCC guideline
criteria (in line with American AASLD criteria): nodule >1 cm in a patient at
risk for HCC, with combination of arterial hypervascularity and venous or
delayed phase wash-out on multiphase CT-scan or MRI-scan.2, 4 LR-5 and LR- 4
based on Liver Imaging Reporting and Data System can be included.
4. No curative treatment options (resection, transplant, or in case of solitary
tumor <5 cm, RFA).
5. Life expectancy of at least 6 months.
6. ECOG Performance status 0-1.
7. Liver-dominant disease (maximum 5 lung nodules all <=1.0 cm, solitary
clinically stable adrenal metastasis, and mesenteric or portal lymph nodes all
<=2.0 cm are accepted).
8. Child-Pugh class A5-6 or B7 (only for patients with known cirrhosis).
9. At least one measurable liver lesion according to the modified RECIST
criteria.
10. Negative pregnancy test for women of childbearing potential. Female
patients of childbearing potential should use a highly effective acceptable
method of contraception (oral contraceptives, barrier methods, approved
contraceptive implant, long-term injectable contraception, intrauterine device
or tubal ligation) or should be more than 1 year postmenopausal or surgically
sterile during their participation in this study (from the time they sign the
consent form), to prevent pregnancy

Exclusion Criteria

A potential subject who meets any of the following criteria will be excluded
from participation in this study:
1. Evidence of significant extrahepatic disease (MRI-scan liver and multiphase
abdominal CT as well as a thoracic CT are routinely performed at screening).
2. Hepatic radiation therapy within the last 4 weeks before the start of study
therapy.
3. Previous or current treatment with RE. Previous treatment with TACE,
surgery, RFA, and previous or current treatment with sorafenib are allowed.
4. Major surgery within 4 weeks or incompletely healed surgical incision before
starting study therapy.
5. Serum bilirubin >34.2 micromole/L (2 mg/dL).
6. Glomerular filtration rate <35 ml/min.
7. Non-correctable INR >1.5 in case of femoral approach (as opposed to radial).
8. Leukocytes <2 109/l and/or platelet count <50 109/l.
9. Significant cardiac event (e.g. myocardial infarction, superior vena cava
(SVC) syndrome, New York Heart Association (NYHA) classification of heart
disease >=2) within 3 months before entry, or presence of cardiac disease that
in the opinion of the investigator increases the risk of ventricular arrhythmia.
10. Pregnancy or breastfeeding.
11. Patients suffering from psychic disorders that make a comprehensive
judgment impossible, such as psychosis, hallucinations and/or depression.
12. Patients who are declared incapacitated.
13. Previous enrollment in the present study.
14. Male patients who are not surgically sterile or do not use an acceptable
method of contraception during their participation in this study (from the time
they sign the consent form), to prevent pregnancy in a partner.
15. Evidence of untreated, clinically significant grade 3 portal hypertension
(i.e. large varices at oesophago-gastro-duodenoscopy). In these cases, therapy
with non-selective beta-blocker (propranolol) or rubber band ligation should be
instituted according to accepted guidelines. In case of small varices,
prophylactic propranolol is advised.
16. Portal vein thrombosis (tumor and/or bland) of the main branch (diagnosed
on contrast enhanced transaxial images). Involvement of the right or left
portal vein branches and more distal is accepted.
17. Untreated active hepatitis. In case of detectable viral HBV load,
appropriate treatment should be instituted.
18. Transjugular intrahepatic portosystemic shunt (TIPS).
19. Body weight over 150 kg (because of maximum table load).
20. Severe allergy for intravenous contrast used (Visipaque®)(because of CT
evaluation, pre-treatment angiography and treatment angiography).
21. Lung shunt >30 Gy, as calculated using scout dose SPECT/CT.
22. Uncorrectable extrahepatic deposition of scout dose activity. Activity in
the falciform ligament, portal lymph nodes and gallbladder is accepted.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Safety, expressed as the rate of unacceptable toxicity.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>• Tumor response.<br /><br>• Biodistribution / Dosimetry.<br /><br>• Changes in tumor marker alpha-fetoprotein (AFP).<br /><br>• Quality of Life (QoL).<br /><br>• Changes in hepatic function as determined by hepatobiliary scintigraphy.<br /><br>• Changes in Child Pugh score.<br /><br>• To compare study results with HEPAR Primary study results.</p><br>

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