T-ACE Oil by TAE/TACE in Patients With Hepatocellular Carcinoma

Exclusion Criteria37

• Major branch of portal vein has been invaded by HCC, extrahepatic metastasis or other malignant tumors (current active malignancy or active malignancy within the past 5 years).
• Eligible for curative surgery or transplant as judged by PI.
• Evidences of decompensation (Meet at least ONE of the following criteria):
• Total Bilirubin \> 2 mg/dL
• INR \> 1.7
• Child-Pugh score \> 8
• refractory ascites
• active bleeding
• hepatic encephalopathy
• severe infection
• Any of the following findings (but not limit to):
• Heart failure (NYHA Class III or IV), COPD (Stage III or IV).
• A marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval \>480 milliseconds (ms) (CTCAE grade 1) using Fridericia's QT correction formula.
• A history of risk factors for torsades de pointes (e.g., heart failure, hypokalemia, family history of Long QT Syndrome) or use of concomitant medications that prolong the QT/QTc interval (e.g., class Ia, Ic or III antiarrhythmic drugs, tricyclic antidepressants or phenothiazines)
• Bronchial asthma that may increase the risk associated with study participation, or may interfere with compliance of the protocol as judged by the PI.
• Renal dysfunction (eGFR \< 50 ml/min/1.73m2 and/or creatinine \> 1.5x ULN), or patients is planned to accept any renal replacement therapy during treatment visits.
• Diagnosed with hyperthyroidism or receiving treatment for hyperthyroidism. Has unstable thyroid function as judged by the PI (e.g. TSH \> 5.0 mIU/L).
• Traumatic injuries, clinically significant hemorrhage/bleeding, or clinically significant gastrointestinal bleeding within 8 weeks.
• Major cardiovascular disease, including stroke and transient ischemic attack (TIA).
• Known homocystinuria.
• Any of the following laboratory findings:
• Absolute Neutrophil Count \< 1000/μL
• Platelets \< 50,000/μL
• Hgb \< 8.5 g/dL
• AST \> 5x ULN
• ALT \> 5x ULN
• Performance status Eastern Cooperative Oncology Group (ECOG) of 2 or more.
• Patients whose blood vessel are too difficult to perform TACE procedure as judged by PI.
• TACE procedure would be performed in areas of the liver where bile ducts are dilated as judged by PI.
• Prominent Hepatic arteriovenous (AV) shunt, as judged by PI.
• Non-targeted area may be endangered during TACE procedure, as judged by PI.
• Patients, who have ever accepted TACE therapy, and cannot gain extra benefits from further embolization treatment.
• Number of HCC tumors more than 10.
• Allergy or contraindication to iodine, Lipiodol, allowed contrast agents, allowed Gelfoam suppositories or allowed artery hemostats.
• Pregnant females or lactating females.
• Male or female subjects with fertility who are unwilling to perform highly effective contraception method.
• Subjects who, in the opinion of the investigator, are not suitable to participate in the trial for whatever reason.