Safety and Feasibility of Radioembolization Using Ho-166 in Patients With Unresectable Hepatocellular Carcinoma

Launched by ERASME UNIVERSITY HOSPITAL · Dec 7, 2022

Keywords

ClinConnect Summary

Primary liver cancer is a growing health problem worldwide. Hepatocellular carcinoma (HCC) represents more than 90% of primary liver cancers and is considered to be the fifth most common cancer and the second leading cause of cancer-related deaths, with the majority being associated to cirrhosis.

Choosing the most suitable treatment option depends not only on the tumor stage, but also on the severity of the underlying liver disease and performance status. Current guidelines consider the Barcelona Clinic Liver Cancer (BCLC) staging system as the algorithm of choice for tumor staging and the...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patients must have given written informed consent
• • Adults ≥ 18 years-old
• • Typical imaging or biopsy proven HCC according to EASL-EORTC guidelines (1)
• • Unresectable disease, BCLC B, or contraindicated for ablation, resection or transplantation, BCLC A, or BCLC C patients with no extra-hepatic extension, patients on the waiting list for resection or transplantation.
• • At least one measurable lesion on multiphasic CT or MRI
• • Preserved liver function with Child- Pugh score≤ B7
• • ECOG performance status ≤ 1 (Table 2)
• • Life expectancy ≥3 months
• • Efficient contraception for women
• • Platelets ≥ 50000/m3 and PT≥ 50%
• • Hemoglobin ≥8.5 g/dl
• • Bilirubin ≤ 2 mg/dl
• • ASAT/ALAT levels ≤ 5x upper normal limit
• • Creatinine ≤ 1.5x upper normal limit
• Exclusion Criteria:
• * Before work-up:
• • History of progressive, uncontrolled cancer other than HCC presenting liver metastasis.
• • \>50% of liver involvement
• • Portal vein thrombosis of the main branch diagnosed on contrast enhanced images. Involvement of the right or left portal main branches and more distal is accepted
• • Evidence of extrahepatic disease
• • Unmanageable intolerance to contrast medium
• • Contraindication to hepatic angiography
• • Digestive hemorrhage due to portal hypertension in the 30 days preceding treatment
• • Previous systemic treatment, radiation therapy, transarterial loco-regional therapy or ablation therapy for HCC
• • Active infection or untreated active hepatitis (if detectable viral HBV load, treatment with a nucleoside analog should be instituted).
• • Pregnancy or breast feeding
• • Ascitis
• • Transjugular intrahepatic portosystemic shunt (TIPS) or portacaval shunt
• • Major surgery withing 4 weeks or incompletely healed surgical incision before starting study therapy
• • Patients suffering from psychic disorders that make a comprehensive judgement impossible, such as psychosis, hallucinations and/or severe depression.
• • Patients who are declared incapacitated
• * After work-up:
• • Lung absorbed dose \> 30 Gy, as calculated using the 166Ho scout dose or 99mTc MAA
• • Uncorrectable extrahepatic deposition of the scout dose activity. Activity in the falciform ligament, portal lymph nodes and gallbladder is accepted.

Trial Officials