Actively Recruiting

Phase 2
Age: 20Years +
All Genders
NCT06632717

Hepatic Arterial Infusion Chemotherapy With Lipiodol Embolization in Advanced Hepatocellular Carcinoma

Led by National Taiwan University Hospital · Updated on 2025-11-25

24

Participants Needed

1

Research Sites

143 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

Hepatic Arterial Infusion Chemotherapy With Lipiodol Embolization in Advanced Hepatocellular Carcinoma

Who Can Participate

Age: 20Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Able to provide signed informed consent and comply with study requirements
  • Diagnosed with hepatocellular carcinoma by biopsy or typical imaging
  • Barcelona Clinic Liver Cancer Stage C disease or Stage B disease after failed, refused, or intolerable standard treatment
  • Archival tissue available within 2 years or agree to biopsy at baseline
  • Age over 20 years at study entry
  • Eastern Cooperative Oncology Group performance status 0 or 1
  • Child-Pugh class A or B7 liver function
  • At least one measurable liver lesion by RECIST 1.1 criteria
  • Body weight over 30 kg
  • Adequate organ and marrow function including hemoglobin ≥9.0 g/dL, neutrophil count ≥1,000/mm3, platelet count ≥75,000/mm3, serum bilirubin ≤2 times upper normal limit, AST/ALT ≤3 times upper normal limit (≤5 times if active liver cancer present), creatinine clearance >40 mL/min
  • Post-menopausal status or negative pregnancy test for pre-menopausal women
  • Willing and able to follow protocol and attend scheduled visits
  • Life expectancy of at least 12 weeks
Not Eligible

You will not qualify if you...

  • Fibrolamellar carcinoma or mixed hepatocellular cholangiocarcinoma
  • Lung perfusion scan result of hepatic artery infusion chemotherapy port >30%
  • Participation in another clinical study except observational or follow-up of interventional studies
  • Receipt of anticancer therapy within 14 days before study treatment
  • Unresolved toxicity Grade 2 or higher from previous therapy except alopecia, vitiligo, or specified lab values
  • Concurrent chemotherapy, investigational product, biologic, or hormonal cancer treatment (non-cancer hormonal therapy allowed)
  • Major surgery within 28 days before study treatment
  • Uncontrolled illness including active infection (except HBV or HCV), heart failure, uncontrolled hypertension, unstable angina, arrhythmia, lung disease, serious gastrointestinal conditions, or psychiatric/social issues affecting compliance
  • History of other primary cancers except specified
  • History of leptomeningeal carcinomatosis
  • Brain metastases or spinal cord compression
  • History of active primary immunodeficiency
  • Active infection including tuberculosis
  • Pregnancy or breastfeeding, or unwillingness to use effective birth control
  • Known allergy or hypersensitivity to study drugs or excipients

AI-Screening

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Trial Site Locations

Total: 1 location

1

National Taiwan University Hospital

Taipei, Taiwan

Actively Recruiting

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Research Team

T

Tsung-Hao Liu, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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