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

Launched by TERUMO EUROPE N.V. · Jul 6, 2022

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ClinConnect Summary

This clinical trial is looking at a new treatment called Holmium-166 Transarterial Radioembolization (166Ho-TARE) for patients with early-stage liver cancer known as hepatocellular carcinoma (HCC) who cannot undergo surgery. The goal is to gather more information about how safe and effective this treatment is for patients who have a limited number of tumors and good liver function but are not candidates for surgery or liver transplants. This study is open to adults aged 18 and older who meet specific health criteria, such as having one main tumor up to 8 cm or up to three smaller tumors, and who have not had certain other treatments for their cancer.

If you participate in this trial, you will receive personalized treatment using 166Ho-TARE, which involves injecting a radioactive substance directly into the blood vessels feeding the tumor. Throughout the study, your health will be monitored closely, and you'll need to give consent before starting. It’s important to know that not everyone with liver cancer will qualify for this trial, especially if there are signs of more advanced disease or other health issues. If you think you might be eligible, it’s a good idea to discuss the details with your healthcare provider.

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Eligibility criteria

• 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