Key Inclusion Criteria
- Unresectable Hepatocellular Carcinoma (HCC)
- Barcelona Clinic Liver Cancer (BCLC) stage C with or without portal vein thrombosis not eligible for surgical resection, liver transplantation nor Radiofrequency ablation (RFA), or
- BCLC stage A/B
- Patients with recurrence of HCC after surgical or loco-regional treatment not eligible for surgical resection, liver transplantation or RFA, or
- Patients who have not achieved an objective response after ≤2 sessions of Transarterial Chemoembolisation (TACE) in the target lesions
- Eastern Cooperative Oncology Group (ECOG) performance status 0–1
- If cirrhosis is present, Child-Pugh class A or B ≤7 points
- Adequate haematological, renal and hepatic function
- Life expectancy >3 months
Key Exclusion Criteria
- Concurrent or previous malignancy other than adequately treated non-melanoma skin cancer or carcinoma in situ of the cervix
- Extrahepatic metastases (except non-specific pulmonary tumours <1 cm and abdominal lymph nodes <2 cm)
- Advanced HCC previously treated with systemic therapy (does not preclude prior TACE or other loco-regional/radical therapies)
- Advanced liver disease with Child-Pugh score >B7, active gastrointestinal bleeding, encephalopathy or refractory ascites
- Pregnant or breast feeding
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Effective May 7, 2021, SIR-Spheres will have the following indication for use:
SIR-Spheres Y-90 resin microspheres are indicated for the treatment of unresectable hepatocellular carcinoma (HCC) and
unresectable metastatic liver tumors from primary colorectal cancer in patients refractory to or intolerant of chemotherapy.