SNMC (Stronger Neo-Minophagen C ) for Acute Hepatitis Post Transarterial Chemoembolization Therapy

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Hepatocellular Carcinoma

Intervention / Treatment
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* Drug: Stronger Neo-Minophagen C


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: randomized control trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SNMC<br> | Drug: Stronger Neo-Minophagen C<br>* intravenous injection after TACE<br>|
| No Intervention: non-SNMC<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Series changes of serum levels of alanine aminotransferase | To evaluate the daily change of serum levels of alanine aminotransferase before and after TACE, which indicate the hepatitis activity caused by TACE | 4 days | 
| Series changes of serum levels of aspartate aminotransferase | To evaluate the daily change of serum levels of aspartate aminotransferase before and after TACE, which indicate the hepatitis activity caused by TACE | 4 days | 
| Series changes of serum levels of Total bilirubin | To evaluate the daily change of serum levels of Total bilirubin before and after TACE, which indicate the hepatitis activity caused by TACE | 4 days | 
| Series changes of Prothrombin Time | To evaluate the daily change of Prothrombin Time before and after TACE, which indicate the hepatitis activity caused by TACE | 4 days | 
| Series changes of Prothrombin Time-Intemrnational Normalized Ratio | 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 | 4 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Series changes of potassium levels before and after TACE | To evaluate the daily change of Series changes of potassium levels before and after TACE, which indicate the side effect caused by SNMC | 4 days | 
| Series changes of blood pressure levels before and after TACE | To evaluate the daily change of Series changes of blood pressure levels before and after TACE, which indicate the side effect caused by SNMC | 4 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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TACE