Hepatic Arterial Infusion Chemotherapy With Lipiodol Embolization in Advanced Hepatocellular Carcinoma

NCT06632717 | Recruiting Phase 2

• 1 other identifier: 202311007MINA
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatocellular Carcinoma

Keywords

Hepatic Arterial Infusional Chemotherapy; Lipiodol Embolization; Hepatocellular carcinoma

Outcome Measures

Primary Outcomes (1)

• Objective response rate (RECIST 1.1)

  To assess the objective response rate (RECIST 1.1) of HAIC-PF + lipiodol embolization.

  From date of randomization until the date of first documented confirmed response rate by RECIST 1.1, assessed up to 60 months

Secondary Outcomes (5)

• Objective response rate (mRECIST)

  From date of randomization until the date of first documented confirmed response rate by mRECIST, assessed up to 60 months

• Liver specific objective response rate (RECIST 1.1 & modified RECIST)

  From date of randomization until the date of first documented liver specific confirmed response rate by RECIST 1.1 & mRECIST, assessed up to 60 months

• Progression-free survival (RECIST 1.1 and modified RECIST)

  From date of randomization until the date of first documented progression (RECIST 1.1 or mRECIST) or date of death from any cause, whichever came first, assessed up to 60months

• Overall survival

  From date of randomization until the date of first documented date of death from any cause, whichever came first, assessed up to 60 months

• Incidence of treatment-emergent adverse events [safety and tolerability]

  From date of randomization until 3 months after the end-of-trial, assessed up to 60months

Study Arms (1)

HAIC-Cisplatin+5-fluorouracil in combination with lipiodol embolization

EXPERIMENTAL

hepatic arterial infusional cisplatin and 5-fluorouracil will be given followed by lipiodol embolization

Drug: Cisplatin; Drug: 5-fluorouracil; Procedure: Lipiodol embolization

Interventions

Cisplatin DRUG

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

HAIC-Cisplatin+5-fluorouracil in combination with lipiodol embolization

5-fluorouracil DRUG

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

Also known as: 5-FU

HAIC-Cisplatin+5-fluorouracil in combination with lipiodol embolization

Lipiodol embolization PROCEDURE

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.

Also known as: ethiodized oil

HAIC-Cisplatin+5-fluorouracil in combination with lipiodol embolization

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• \. 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.
• \. Must have a life expectancy of at least 12 weeks

You may not qualify if:

• Fibrolamellar carcinoma or mixed hepatocellular cholangiocarcinoma
• The result of lung perfusion scan of the HAIC port \> 30%
• Concurrent enrolment in another clinical study, unless it is an observational (non-interventional) clinical study or during the follow-up period of an interventional study
• Receipt of the last dose of anticancer therapy (chemotherapy, immunotherapy, endocrine therapy, targeted therapy, biologic therapy, tumor embolization, monoclonal antibodies) ≤14 days prior to the first dose of the study drug. If sufficient wash-out time has not occurred due to the schedule or PK properties of an agent, a longer wash-out period will be required, as agreed by the principal investigator.
• Any concurrent chemotherapy, IP, biologic, or hormonal therapy for cancer treatment. Concurrent use of hormonal therapy for non-cancer-related conditions (e.g., hormone replacement therapy) is acceptable.
• Major surgical procedure (as defined by the Investigator) within 28 days prior to the first dose of study treatment.
• Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection (except HBV infection or HCV infection), symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, interstitial lung disease, serious chronic gastrointestinal conditions associated with diarrhea, or psychiatric illness/social situations that would limit compliance with study requirement, substantially increase risk of incurring AEs or compromise the ability of the patient to give written informed consent
• History of another primary malignancy except for conditions listed in the protocol.
• History of leptomeningeal carcinomatosis
• Brain metastases or spinal cord compression. Patients with suspected brain metastases at screening should have an MRI (preferred) or CT each preferably with IV contrast of the brain prior to study entry
• History of active primary immunodeficiency
• Active infection including tuberculosis (clinical evaluation that includes clinical history, physical examination and radiographic findings, and TB testing in line with local practice)
• Female patients who are pregnant or breastfeeding or male or female patients of reproductive potential who are not willing to employ effective birth control from screening to 90 days after the last dose of the trial treatment.
• Known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients.

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Cisplatin; Fluorouracil; Ethiodized Oil

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Iodized Oil; Plant Oils; Oils; Lipids; Plant Preparations; Biological Products; Complex Mixtures

Study Officials

• Tsung-Hao Liu, MD

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tsung-Hao Liu, MD

CONTACT

+88623123456; thliu@ntuh.gov.tw

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2024
• First Posted: October 9, 2024
• Study Start: September 1, 2024
• Primary Completion: January 31, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: November 25, 2025

Record last verified: 2025-11

Locations

TW (1)