NIPH Clinical Trials Search

Epi-WOW TACE

Basic Information

Recruitment status	Recruiting
Health condition(s) or Problem(s) studied	(1): Insufficient efficacy or worsening of symptoms, making it difficult to continue the study.
Date of first enrollment	21/02/2025
Target sample size	2
Countries of recruitment
Study type	Interventional
Intervention(s)	Intra-hepatic arterial injection

Outcome(s)

Primary Outcome

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

Secondary Outcome

(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)

Key inclusion & exclusion criteria

Age minimum	>= 18age old
Age maximum	Not applicable
Gender	Both
Include criteria	(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
Exclude criteria	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.