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Clinical Application of a New Hepatic Arterial Chemotherapy using Epirubicin-entrapped WOW-type Lipiodol Emulsions prepared with a Novel Membrane Emulsification Mixing Device for Primary Hepatocellular Carcinoma

Epi-WOW TACE

Yanagie Hironobu

Keiai-kai Kojin Hospital

28 Izumita, Nakaota, Morioka City, Iwate

h.yanagie@gmail.com

Yanagie Hironobu

Keiai-kai Kojin Hospital

28 Izumita, Nakaota, Morioka City, Iwate

+81-19-656-2888

h.yanagie@gmail.com

Recruiting

Feb. 21, 2025

Interventional

single arm study

open(masking not used)

active control

single assignment

treatment purpose

(1): As a general rule, applicants must be at least 18 years of age.
2): Patients diagnosed with hepatocellular carcinoma by histological or imaging diagnosis (CT scan, MRI, etc.)
3): Patients with advanced or recurrent cancer who are unable to undergo surgery, who refuse surgery, or who have a strong possibility that surgery will have a significant adverse effect on their quality of life.
4): Patients with advanced or recurrent cancer who are difficult to cauterize, who refuse cauterization, or who are determined to be unresponsive to cauterization.
5): Patients with measurable lesions (CT with a long diameter of 10 mm or more, chest radiograph with a long diameter of 20 mm or more, and lymph node lesions with a short diameter of 15 mm or more).
6): Patients who have undergone prior chemotherapy, surgical therapy for more than 4 weeks, percutaneous ethanol injection, radiofrequency ablation, or immunotherapy for more than 2 weeks.
7) Patients with adequate bone marrow, liver, and renal function (clinical laboratory values in the registry meet the following criteria)
White blood cell count > 3,000/mm3 and platelet count > 100,000/mm3
Transaminases less than or equal to 100 IU/l and serum total bilirubin less than or equal to 2.0 mg/dl
Child-Pugh classification A or B
Estimated Glomerular Filtration Rate : more than 45
8): Patients with abnormal or high values of any of the tumor markers AFP, AFP-L3 fraction, or PIVKA-II
9): Patients who have given written and oral explanations and obtained written consent

1): Patients with poor general condition (PS: Performace Status 3 or higher) (see Table 1)
2): Patients whose parents or siblings have bronchial asthma, rash, urticaria, or other allergic reactions (Contraindication of Lipiodol)
3): Patients with thyroid disorders (Contraindication of Lipiodol)
4): Patients with a history of severe drug hypersensitivity or drug allergy
5): Patients who are deemed to be unable to register due to clinically significant mental or neurological disorders
6): Pregnant, lactating, or possibly pregnant
7): Other cases that the investigator deems inappropriate to participate in this study.

Both

(1): Insufficient efficacy or worsening of symptoms, making it difficult to continue the study.

Intra-hepatic arterial injection

Intra-hepatic arterial injection

Local treatment effect and tumor shrinkage. RECIST Guideline version 1.116 21.
The reduction in size of the subject cancer will be recorded on the case report form by the principal investigator according to the prescribed criteria. The final judgment of the effect will be made by the principal investigator and the subinvestigator based on the records. The tumor length and diameter are measured and summed, and the shrinkage rate is calculated.
(1) CR (complete response): Complete disappearance (lymph node metastases less than 10 mm in short diameter)
(2) PR (partial response): Reduction of 30% or more
(3) SD (stable disease): No CR, PR, or PD after 4 weeks of evaluation.
(4) PD (progressive disease): 20% or more increase from the minimum value after the baseline and 5 mm or more increase in absolute value

(1) Patient safety
1) Systemic symptoms and skin symptoms after hepatic infusion
2) Blood test data Comparison of blood test data (white blood cell count, platelet count, etc.) before and after hepatic infusion before and after hepatic infusion

(2) Evaluation of antitumor effects based on reduction in tumor marker values (AFP, PIVKA-II, and AFP-L3 fraction)

+81-25-368-9343

Dec. 23, 2024

No

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