Hepatic Arterial Infusion Chemotherapy With Lipiodol Embolization in Advanced Hepatocellular Carcinoma
Trial Parameters
Brief Summary
Hepatic artery infusion chemotherapy (HAIC) is a locoregional therapy commonly used in hepatocellular carcinoma (HCC), with high response rates and minimal impairment of liver function reported. Transarterial chemoembolization (TACE) and transarterial embolization (TAE) are also commonly used in HCC, with high response rates reported yet carry risks of impairing liver function after repeated embolization with a definitive embolic agent. On the other hand, lipiodol used in TACE/TAE has transient and plastic embolization effects on the tumor in contrast to the long-lasting embolization effect of the definitive embolic agent. This study investigates whether combining HAIC with lipiodol embolization will increase efficacy with good liver function preservation.
Eligibility Criteria
Inclusion Criteria: 1. Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF). 2. Histologically or clinically (typical HCC imaging findings by multi-phase CT or MRI) diagnosed HCC. 3. Barcelona Clinic Liver Cancer (BCLC) Stage C disease (liver confined disease or liver predominant disease, as determined by the investigator) or BCLC Stage B disease who failed standard treatment (i.e., TACE in intermediate stage HCC or systemic therapy in advanced HCC) or refused standard treatment or intolerable to standard treatment. 4. Archival tissue available (\< 2 years) or agree to have biopsy tissue at baseline 5. Age \> 20 years at the time of study entry. 6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 7. Child-Pugh class A or B7 8. ≥1 measurable lesion per Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 in the liver 9. Body weight \>30 kg 10. Adequate normal organ