NCT06632717

Hepatic Arterial Infusion Chemotherapy With Lipiodol Embolization in Advanced Hepatocellular Carcinoma

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: National Taiwan University Hospital · Academic / Other
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Hepatic artery infusion chemotherapy (HAIC) is an effective locoregional therapy commonly utilized in hepatocellular carcinoma (HCC). The rationale for the anti-tumor efficacy of HAIC is to deliver high local concentrations of chemotherapeutic agents to the liver tumor. Previous studies on HAIC alone or in combination with other systemic therapies have demonstrated excellent intrahepatic tumor contr rates and survival benefits. The investigators have previously conducted a pilot study of HAIC in National Taiwan University Hospital (NTUH) using cisplatin and 5-fluorouracil and demonstrated a high response rate of 26% in advanced HCC patients. In addition to the observed efficacy, HAIC does not impair liver function significantly over repeated administration and can be safely given to patients with poor or limited liver reserve. Transarterial chemoembolization (TACE) and transarterial embolization (TAE) are the most recognized standard treatment in intermediate-stage HCC and are also commonly utilized in advanced-stage HCC. TACE procedure is based on administering a cytotoxic drug mixed with lipiodol followed by definitive embolization of the tumor-feeding arteries by an embolic agent. However, repeated embolization can impair liver function and jeopardize the chance of patients receiving further salvage treatment. Lipiodol used in TACE/TAE has transient and plastic embolization effects on the tumor in contrast to the long-lasting embolization effect of the embolic agent, such as Gelfoam. Performing embolization with lipiodol alone without an embolic agent may limit detrimental effects on the normal liver and help preserve liver function in patients with HCC. The investigators hypothesize that combining HAIC and transient embolization using lipiodol may have enhanced efficacy compared to HAIC alone. In addition, the unwanted liver function impairment caused by repeated embolization is alleviated by the characteristic transient embolization effect of lipiodol. Thus, The investigators propose this prospective, single-arm, phase 2 pilot study comprising HAIC with cisplatin and 5-fluorouracil in combination with lipiodol embolization to investigate its efficacy and safety in patients with advanced HCC.

Conditions

• Hepatocellular Carcinoma

Interventions

Type	Name	Description
DRUG	Cisplatin	Chemotherapy regimen • Cisplatin 60mg/m2 on day 2; 5-fluorouracil (5-FU) 500mg/m2 on day 1 - day 3 via the HAIC port, every 3 weeks until progression or intolerable toxicity
DRUG	5-fluorouracil	Chemotherapy regimen • Cisplatin 60mg/m2 on day 2; 5-fluorouracil (5-FU) 500mg/m2 on day 1 - day 3 via the HAIC port, every 3 weeks until progression or intolerable toxicity
PROCEDURE	Lipiodol embolization	Lipiodol embolization protocol * Lipiodol embolization will be performed on day 3 after completion of 5-FU infusion, up to 4 cycles. Fixed dose lipiodol of 10mL will be given on day 3 followed by 30mL normal saline flush. * The administration of lipiodol is mandatory on cycle 1. The administration of lipiodol on cycle 2 to cycle 4 will depend on the discretion of the treating physician and the presence of adverse effects from lipiodol embolization.

Timeline

• Start date: 2024-09-01
• Primary completion: 2026-01-31
• Completion: 2027-06-01
• First posted: 2024-10-09
• Last updated: 2025-11-25

Locations

1 site across 1 country: Taiwan