jRCTs031240700招募中不适用
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
未提供0 个研究点目标入组 2 人开始时间: 待定最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 2
- 主要终点
- Local treatment effect
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Single Arm Study
- 干预模型
- Single Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 18age old over 至 No limit（—）
- 性别
- All
入选标准
- •(1): As a general rule, applicants must be at least 18 years of age.
- •: Patients diagnosed with hepatocellular carcinoma by histological or imaging diagnosis (CT scan, MRI, etc.)
- •: 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.
- •: Patients with advanced or recurrent cancer who are difficult to cauterize, who refuse cauterization, or who are determined to be unresponsive to cauterization.
- •: 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).
- •: 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.
- •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
- •: Patients with abnormal values of any of the tumor markers AFP, AFP-L3 fraction, or PIVKA-II
- •: Patients who have given written and oral explanations and obtained written consent
排除标准
- •: Patients with poor general condition (PS: Performace Status 3 or higher) (see Table 1)
- •: Patients whose parents or siblings have bronchial asthma, rash, urticaria, or other allergic reactions (Contraindication of Lipiodol)
- •: Patients with thyroid disorders (Contraindication of Lipiodol)
- •: Patients with a history of severe drug hypersensitivity or drug allergy
- •: Patients who are deemed to be unable to register due to clinically significant mental or neurological disorders
- •: Pregnant, lactating, or possibly pregnant
- •: Other cases that the investigator deems inappropriate to participate in this study.
结局指标
主要结局
Local treatment effect
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.
Tumor shrinkage
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
次要结局
- Systemic symptoms and skin symptoms after hepatic infusion
- Blood test data Comparison of blood test data (white blood cell count, platelet count, etc.) before and after hepatic infusion
- Evaluation of antitumor effects based on reduction in tumor marker values (AFP, PIVKA-II, and AFP-L3 fraction)
研究者
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