Safety and Efficacy of TareSphere in Patients With Unresectable Hepatocellular Carcinoma

Exclusion Criteria

• •1. With the extrahepatic metastasis or concurrent malignant tumors other than liver cancer;
• •2. With the hepatic tumor thrombus (excluding the thrombus limited to liver segments or lobes);
• •3. With hepatic artery malformation and unable to intubate hepatic artery;
• •4. Allergy to contrast agents or anesthetics;
• •5. Severe pulmonary dysfunction (forced expiratory volume in one second, FEV1/FVC \< 50 percent or forced expiratory volume in one second (FEV1) \< 50 percent of predicted value, or maximum voluntary ventilation (MVV) \< 50 L/min);
• •6. With the clinical manifestations of decompensated liver cirrhosis (moderate or severe ascites, upper gastrointestinal bleeding, hepatic encephalopathy, etc.);
• •7. With diseases have not been controlled despite aggressive treatment, and which may affect the safety or the efficacy of the investigational drug in the judgement of investigators;
• •8. Active or severely infected participants requiring systemic therapy;
• •9. With positive results of HIV antibody test;
• •10. Estimated survival period \< 3 months;
• •11. Have received radiotherapy or transcatheter arterial chemoembolization (participants who have received transcatheter arterial non-iodized oil chemoembolization are judged by investigators);
• •12. Technetium (99mTc)-macroaggregated albumin (MAA) hepatic arterial perfusion imaging estimates that the NRT6003 injection cannot cover all lesions within the liver (excluding lesions previously treated by the investigator as non-active or non-progressive);
• •13. Hepatic artery angiography and 99mTc-MAA hepatic artery perfusion imaging demonstrate gastrointestinal shunts, which may not be remedied through vascular intervention techniques;
• •14. 99mTc-MAA arterial perfusion imaging shows that the single lung radiation absorbed dose \> 30 Gy;
• •15. Received antitumor therapy or participated in other interventional clinical trials within 30 days prior to dosing;
• •16. Pregnant or lactating women;
• •17. Have persistent, unrelieved toxicity reaction of CTCAE≥2 grade caused by previous antitumor treatment (excluding alopecia) judged by investigators;
• •18. Any other reason that the investigator deems the participant unsuitable for participating in this trial.