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临床试验/NCT04015245
NCT04015245已完成4 期

Benefits of SNMC (Stronger Neo-Minophagen C ) for Heptoma Patient With Acute Hepatitis Post Transarterial Chemoembolization Therapy

Chimei Medical Center1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2018年4月12日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
60
试验地点
1
主要终点
Series changes of Prothrombin Time

研究概览

简要总结

A glycyrrhizin-containing product, Stronger Neo-Minophagen C TM (SNMC; Minophagen Pharmaceutical Co.Ltd.,Tokyo,Japan),is widely used in Japan for suppression of hepatitis activity and for prevention of disease progression in patients with hepatitis B virus- and HCV-induced chronic hepatitis. In Taiwan, SNMC has been licensed by Taiwan Food and Drug Administration for the indication of maintain hepatic function. Glycyrrhizin has been reported to mitigate hepatic inflammation by suppressing elevated alanine aminotransferase(ALT) levels and preventing disease progression. The effect of SNMC on acute deterioration of hepatic function following transarterial chemoembolization (TACE) was still unknown. This study aimed to evaluate the effect of SNMC on acute deterioration of hepatic function following TACE.

详细描述

Hepatocellular carcinoma (HCC) is the fifth most common cancer in the world and the most common primary liver cancer. There are a variety of therapies for treatment of HCC; among them, transarterial chemoembolization (TACE) is one of the most commonly used treatment modalities. TACE induces ischemic tumor necrosis by obstruction of hepatic artery blood flow and exerts an anticancer effect via chemotherapeutic agents such as adriamycin or cisplatin mixed with Lipiodol. In the American Association for the Study of Liver Diseases (AASLD) guidelines for the management of HCC, TACE is recommended for patients with intermediate-stage HCC according to the Barcelona Clinic Liver Cancer (BCLC) staging system, because TACE was found to improve survival compared with the best supportive care in patients with unresectable HCC. Although TACE is the established standard of care only for intermediate-stage HCC, in recent years, TACE has been used widely even in treatment of advanced-stage HCC. The most frequent side effects of TACE are fever, nausea, and abdominal pain, and these side effects are self-limiting in the majority of patients. However, acute deterioration of hepatic function following TACE is a potentially life-threatening complication that occasionally interferes with continuation of TACE in patients with HCC. Although TACE has marked direct antitumor effects, it can also result in more complications than conservative management, because the ischemic damage caused by TACE can influence not only tumor tissue but non-tumorous liver tissue.This study aimed to evaluate the effect of SNMC on acute deterioration of hepatic function following TACE.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Intermediate-stage HCC according to the Barcelona Clinic Liver Cancer (BCLC) staging system, either treatment naïve or experienced.
  • Child's score belong to A or B(7)
  • Total bilirubin level <2 and Prothrombin time prolong <3"

排除标准

  • Had history of liver decompensation (ascites, encephalopathy, jaundice and varices bleeding) before this TACE
  • has allergic history of SNMC
  • consensus form cannot be available
  • hypokalemia (<3.5 mmol/L)

研究组 & 干预措施

SNMC

Experimental

干预措施: Stronger Neo-Minophagen C (Drug)

结局指标

主要结局

Series changes of Prothrombin Time

时间窗: 4 days

To evaluate the daily change of Prothrombin Time before and after TACE, which indicate the hepatitis activity caused by TACE

Series changes of serum levels of alanine aminotransferase

时间窗: 4 days

To evaluate the daily change of serum levels of alanine aminotransferase before and after TACE, which indicate the hepatitis activity caused by TACE

Series changes of serum levels of Total bilirubin

时间窗: 4 days

To evaluate the daily change of serum levels of Total bilirubin before and after TACE, which indicate the hepatitis activity caused by TACE

Series changes of Prothrombin Time-Intemrnational Normalized Ratio

时间窗: 4 days

To evaluate the daily change of Series changes of Prothrombin Time-Intemrnational Normalized Ratio before and after TACE, which indicate the hepatitis activity caused by TACE

Series changes of serum levels of aspartate aminotransferase

时间窗: 4 days

To evaluate the daily change of serum levels of aspartate aminotransferase before and after TACE, which indicate the hepatitis activity caused by TACE

次要结局

  • Series changes of potassium levels before and after TACE(4 days)
  • Series changes of blood pressure levels before and after TACE(4 days)

研究者

发起方
Chimei Medical Center
申办方类型
Other
责任方
Principal Investigator
主要研究者

Hsing-Tao Kuo

attending physician

Chimei Medical Center

研究点 (1)

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