Efficacy and Safety of Hepatic Arterial Infusion Chemotherapy With Cisplatin and Fluorouracil in Combination With Lipiodol Embolization in Advanced Hepatocellular Carcinoma - a Prospective, Single-arm, Phase 2 Pilot Study
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.
• Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF).
• Histologically or clinically (typical HCC imaging findings by multi-phase CT or MRI) diagnosed HCC.
• 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.
• Archival tissue available (\< 2 years) or agree to have biopsy tissue at baseline
• Age \> 20 years at the time of study entry.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
• Child-Pugh class A or B7
• ≥1 measurable lesion per Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 in the liver
• Body weight \>30 kg
⁃ Adequate normal organ and marrow function as defined below:
‣ (1) Hemoglobin ≥9.0 g/dL (2) Absolute neutrophil count (ANC) ≥1.0 x 109/L (≥ 1,000 per mm3) (3) Platelet count ≥75 x 109/L (≥75,000 per mm3) (4) Serum bilirubin ≤2 x institutional upper limit of normal (ULN). (5) AST (SGOT)/ALT (SGPT) ≤3x institutional upper limit of normal unless active liver malignancies are present, in which case it must be ≤5x ULN (6) Measured creatinine clearance (CL) \>40 mL/min or Calculated creatinine CL\>40 mL/min by the Cockcroft-Gault formula (Cockcroft and Gault 1976) or by 24-hour urine collection for determination of creatinine clearance: 11. Evidence of post-menopausal status or negative urinary or serum pregnancy test for female pre-menopausal patients. Women will be considered post-menopausal if they have been amenorrheic for 12 months without an alternative medical cause.
‣ 12\. Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up.
‣ 13\. Must have a life expectancy of at least 12 weeks