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.
Click here to view our Technical Bulletin.