Hepatic arterial infusion chemotherapy combined with lipiodol embolization for advanced liver cancer

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

This study is testing a new way to treat advanced liver cancer by combining two treatments, chemotherapy delivered directly to the liver and a special oil, to see if it works better and is safer for patients.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 24 (estimated)
• Ages: 20 Years and up
• Sex: All
• Sponsor: National Taiwan University Hospital (Academic / other)
• Drugs / interventions: chemotherapy, immunotherapy
• Locations: 1 site (Taipei)
• Trial ID: NCT06632717 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the combination of hepatic arterial infusion chemotherapy (HAIC) with lipiodol embolization in patients with advanced hepatocellular carcinoma (HCC). The approach aims to deliver high concentrations of chemotherapy directly to liver tumors while preserving liver function. The study builds on previous findings that HAIC alone has shown high response rates and minimal liver impairment. Participants will receive cisplatin and 5-fluorouracil along with lipiodol to evaluate the efficacy and safety of this combined treatment.

Who should consider this trial

Good fit: Ideal candidates include adults over 20 years old with advanced HCC who have either failed standard treatments or are intolerant to them.

Not a fit: Patients with Child-Pugh class C liver disease or those with no measurable lesions in the liver may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could improve tumor response rates and maintain liver function in patients with advanced HCC.

How similar studies have performed: Previous studies have shown promising results with HAIC, indicating that this combined approach may enhance treatment efficacy.

Eligibility criteria

Inclusion Criteria:

1. Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF).
2. Histologically or clinically (typical HCC imaging findings by multi-phase CT or MRI) diagnosed HCC.
3. 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.
4. Archival tissue available (\< 2 years) or agree to have biopsy tissue at baseline
5. Age \> 20 years at the time of study entry.
6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
7. Child-Pugh class A or B7
8. ≥1 measurable lesion per Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 in the liver
9. Body weight \>30 kg
10. 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

Exclusion Criteria:

1. Fibrolamellar carcinoma or mixed hepatocellular cholangiocarcinoma
2. The result of lung perfusion scan of the HAIC port \> 30%
3. 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
4. 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.
5. Any unresolved toxicity NCI CTCAE Grade ≥2 from previous anticancer therapy with the exception of alopecia, vitiligo, and the laboratory values defined in the inclusion criteria.
6. 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.
7. Major surgical procedure (as defined by the Investigator) within 28 days prior to the first dose of study treatment.
8. 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
9. History of another primary malignancy except for conditions listed in the protocol.
10. History of leptomeningeal carcinomatosis
11. 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
12. History of active primary immunodeficiency
13. Active infection including tuberculosis (clinical evaluation that includes clinical history, physical examination and radiographic findings, and TB testing in line with local practice)
14. 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.
15. Known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients.

Where this trial is running

Taipei

• National Taiwan University Hospital — Taipei, Taiwan (Recruiting)

Study contacts

• Principal investigator: Tsung-Hao Liu, MD — National Taiwan University Hospital
• Study coordinator: Tsung-Hao Liu, MD

Conditions Hepatocellular Carcinoma; Hepatic Arterial Infusional Chemotherapy; Lipiodol Embolization; Hepatocellular carcinoma