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Hepatic Arterial Infusion Chemotherapy With Lipiodol Embolization in Advanced Hepatocellular Carcinoma

NCT06632717 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2025-11-25

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • National Taiwan University Hospital

    lead OTHER

Principal Investigators

  • Tsung-Hao Liu, MD · National Taiwan University Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-09-01
Primary Completion
2026-01-31
Completion
2027-06-01

Countries

  • Taiwan

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06632717 on ClinicalTrials.gov