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临床试验/NCT07178093
NCT07178093招募中不适用

Effects of Antrodia Cinnamomea on the Hepatoma Patients After Transcatheter Hepatic Artery Chemoembolization

Taichung Tzu Chi Hospital1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2023年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
60
试验地点
1
主要终点
Changes of serum Aspartate Transaminase (AST) level after TACE

研究概览

简要总结

Effects of Antrodia cinnamomea on the hepatoma patients after Transcatheter hepatic artery chemoembolization

详细描述

Hepatocellular carcinoma (HCC) accounts for 7% of all cancers worldwide and is the most common, primary liver malignancy globally. It is the second leading cause of cancer-related mortality in Taiwan. Most of the patients with HCCs are associated with hepatitis virus B or C infection, and combined with abnormal liver function or liver cirrhosis. The treatment of HCC includes curative treatment, including surgical resection, liver transplantation, and radiofrequency ablation. Non-curative treatment includes Transcatheter hepatic artery chemoembolization or medical therapy, such as target therapies or immunotherapies. Some patients suffered from post-TACE syndrome, e.g., abdominal pain, nausea, fever, or impaired liver function, after TACE. The clinical application was limited by the possibility of liver function deterioration. There is no standard treatment for the post-TACE syndrome currently. Therapies capable of liver protection could enhance the safety and effect of TACE.

Antrodia cinnamomea (AC) is a medicinal fungal species that has been widely used as a healthy food in Taiwan for the treatment of diverse health-related conditions, in recognition of its anticancer, hepatoprotective, anti-inflammatory, antidiabetic and neuroprotective activities. The properties of antitumor and hepatoprotective make A. cinnamomea extract or its major compounds an ideal candidate for enhancing the treatment effect for HCC.

Many cancer patients in Taiwan took Antrodia cinnamomea products during the course of therapies. In this study, we want to elucidate the effect of Antrodia cinnamomea on the hepatoma patients after Transcatheter hepatic artery chemoembolization, such as the improvement of post-TACE syndrome ( liver function impairment, fever, nausea, and abdominal pain), the quality of life, and hospital stay, etc.

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
Triple (Participant, Care Provider, Investigator)

入排标准

年龄范围
20 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Sign the informed consent form
  • Aged between 20 and 80
  • Child-Pugh score class A, B
  • Serum bilirubin level ≤ 1.5 times the upper limit of normal, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels ≤ 2 times the upper limit of normal

排除标准

  • Unwillingness to sign the informed consent form
  • Child-Pugh score class C
  • Patients with main portal vein thrombosis
  • Patients with diffuse liver tumors
  • Those who are allergic to the contrast medium
  • Those with abnormal coagulation function
  • Those with severe dysfunction of brain, heart and lung
  • Patients with severe renal dysfunction (except those receiving renal dialysis)
  • Unable to cooperate
  • Those with uncontrolled arrhythmia and unstable blood pressure
  • Some patients with abnormal thyroid function
  • Any other contraindications such as active gastrointestinal bleeding, refractory ascites, or severe portal hypertension
  • Pregnant or lactating women

结局指标

主要结局

Changes of serum Aspartate Transaminase (AST) level after TACE

时间窗: 28 days

The serum Aspartate Transaminase (AST) levels after TACE day 1, day 3, day 7, day 28 are compared to the baseline.

Changes of serum Alanine Aminotransferase (ALT) level after TACE

时间窗: 28 days

The serum Alanine Aminotransferase (ALT) levels after TACE day 1, day 3, day 7, day 28 are compared to the baseline.

Changes of serum total bilirubin level after TACE

时间窗: 28 days

The serum total bilirubin levels after TACE day 1, day 3, day 7, and day 28 are compared to the baseline

Changes of serum albumin level after TACE

时间窗: 28 days

The serum albumin levels after TACE day 1, day 3, day 7, and day 28 are compared to the baseline

Changes of prothrombin time after TACE

时间窗: 28 days

The prothrombin time after TACE day 1, day 3, day 7, and day 28 are compared to the baseline.

次要结局

  • Improvement of the quality of life(28 days)

研究者

发起方
Taichung Tzu Chi Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Yu, Cheng-Chan

Principal Investigator

Taichung Tzu Chi Hospital

研究点 (1)

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