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临床试验/NCT02061956
NCT02061956已完成不适用

A Simple Prognostic Scoring System for Patients Receiving Transarterial Chemoembolization for Hepatocellular Carcinoma

Sun Yat-sen University1 个研究点 分布在 1 个国家目标入组 647 人开始时间: 2011年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
647
试验地点
1
主要终点
Efficacy

研究概览

简要总结

Hepatocellular carcinoma (HCC) is the 6th most common cancer worldwide and the third most frequent cause of death of cancer.Although with the development of medical science, more and more patients diagnose HCC at early stage, a lot of patients with HCC still continue to present with multiple tumors or port vein thrombosis. According to AASLD guidelines, these patients could received transcatheter arterial chemoembolization (TACE) or new agents as initial treatment. However, the intermediate group comprises a wide spectrum in terms of liver function and extent of tumour, and this may explain the large differences in survival reported for individual series.

A simple, pragmatic and reliable prognostic index based on objective measures would be of value in providing information to patients, for stratifying patients entering clinical trials and in making meaningful comparisons between series reported in the literature.The aims of our study were (i) to identify predictors of survival in a cohort of patients undergoing TACE or TAE for unresectable HCC, (ii) to develop and validate a simple scoring system and (iii) to compare the new scoring system with the most frequently used prognostic systems for its ability to separate high- and low-risk patients.

详细描述

Hepatocellular carcinoma (HCC) is the 6th most common cancer worldwide and the third most frequent cause of death of cancer. The 2005 guidelines of the American Association for the Study of Liver Diseases (AASLD) for HCC states that hepatic resection(HR) can be offered to patients with a solitary lesion if they are non-cirrhotic, or have cirrhosis but still have well-preserved liver function. With the improvement of surgical technique and perioperative care, the surgical mortality for HCC resection can be reduced to less than 1%, and the 5-year overall survival can exceed 50%. Although with the development of medical science, more and more patients diagnose HCC at early stage, a lot of patients with HCC still continue to present with multiple tumors or port vein thrombosis. According to AASLD guidelines, these patients could received transcatheter arterial chemoembolization (TACE) or new agents as initial treatment. However, the intermediate group comprises a wide spectrum in terms of liver function and extent of tumour, and this may explain the large differences in survival reported for individual series.

A simple, pragmatic and reliable prognostic index based on objective measures would be of value in providing information to patients, for stratifying patients entering clinical trials and in making meaningful comparisons between series reported in the literature.The aims of our study were (i) to identify predictors of survival in a cohort of patients undergoing TACE or TAE for unresectable HCC, (ii) to develop and validate a simple scoring system and (iii) to compare the new scoring system with the most frequently used prognostic systems for its ability to separate high- and low-risk patients.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • age between 18-75 years;
  • Child-Pugh A or B liver function;
  • Eastern Cooperative Oncology Group (ECOG) performance scores ≤2;
  • HCC with no previous treatment;

排除标准

  • severe coagulopathy (prothrombin activity <40% or a platelet count of <40,000/mm3);
  • Child-Pugh C liver function or evidence of hepatic decompensation including ascites, esophageal or gastric variceal bleeding, or hepatic encephalopathy;
  • (4) ECOG scores 3-4 (5) combined with serious diseases of other organs.

结局指标

主要结局

Efficacy

时间窗: 1 year

1-year overall survival

次要结局

  • Safety(1 month)

研究者

发起方
Sun Yat-sen University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Chen Min-Shan

Professor

Sun Yat-sen University

研究点 (1)

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