Holmium-166 Transarterial Radioembolization in Unresectable, Early Stage Hepatocellular Carcinoma. (HOMIE-166)

This is an interventional treatment trial for Hepatocellular Carcinoma focused on measuring early stage HCC, TARE, SIRT, radioembolization, Holmium-166 Read More

Inclusion Criteria:

1. Age ≥ 18 years
2. Multidisciplinary tumor board decision for locoregional treatment
3. Freely given, written informed consent
4. Patients with unresectable HCC with a single nodule ≤ 8 cm or up to three nodules with a diameter of ≤ 5 cm (each) eligible for selective radioembolization (including position changes of infusion catheters)
5. Non-cirrhotic patients or Child-Pugh A cirrhosis
6. ECOG performance status 0-1
7. Using an acceptable method of contraception throughout the study until survival follow up (for subjects of childbearing potential)
8. Adequate hematological, renal and liver function.

Adequate hematological function defined as:

• Hemoglobin ≥ 6 mmol/L (9.7 g/dL)
• WBC ≥ 3.0 x 10E9/L
• Absolute neutrophil count ≥ 1.5 x 10E9/L
• Platelet count ≥ 50,000/mm3

Adequate renal function defined as:

• Serum urea and serum creatinine < 1.5 times upper limit of normal (ULN)
• Creatinine clearance ≥ 45 ml/min

Adequate liver function defined as:

• Total bilirubin ≤ 35µmol/L (2.05 mg/dL)
• Albumin ≥ 30 g/L
• AST and ALT ≤ 5X ULN

Exclusion Criteria:

1. Diffuse and/or infiltrative HCC (defined as HCC consisting of multiple tiny liver nodules spreading throughout the entire liver or entire lobe, without a dominant nodule)
2. Hypoperfused HCC (defined as a lack of tumor blush (i.e. reduced or no uptake of contrast fluid) observed on the intra-procedural CT)
3. No full, selective arterial coverage on intra-procedural CT
4. Life expectancy < 6 months
5. Child-Pugh score ≥7 points
6. Prior liver transplantation
7. Prior locoregional or systemic anti-cancer therapy for HCC and previous malignancies
8. Macrovascular invasion (defined as macrovascular invasion of the hepatic and/or portal vein main branches)
9. Extrahepatic metastases
10. Clinically significant ascites
11. Hepatic encephalopathy
12. Untreated active hepatitis B and/or C

13. Work-up imaging showing:

    • Lung shunt > 30 Gy is simulated on 166Ho-scout imaging; or
    • Uncorrectable extrahepatic deposition of simulated 166Ho-scout dose activity. Activity in the falciform ligament, portal lymph nodes and gallbladder is accepted; or
    • Anticipated ineffective tumor targeting (< 150 Gy mean tumor simulated absorbed dose) of 166Ho-scout for each lesion; or
    • Entire tumor burden not within the perfused liver volume (possible extrahepatic collateral supply of the tumor); or
    • Perfused liver volume > 50% of whole liver tissue
14. Pregnant or breast-feeding
15. Current or history of cancer other than HCC, except adequately treated non-melanoma skin cancer or carcinoma in situ of the cervix
16. In the Investigator's opinion there is a reason that could limit the patient's ability to participate in the study, compliance with follow-up requirements or impact the scientific integrity of the study
17. Concurrently enrolled in another study, unless it is an observational non-interventional study