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临床试验/NCT02525952
NCT02525952Unknown不适用

A Randomized Controlled Trial to Compare the Outcomes Between Hepatectomy and Transarterial Chemoembolization for Patients With Multiple Hepatocellular Carcinomas Based on the NDR Scoring System

Eastern Hepatobiliary Surgery Hospital1 个研究点 分布在 1 个国家目标入组 320 人开始时间: 2015年10月最近更新:
适应症

试验速览

阶段
不适用
入组人数
320
试验地点
1
主要终点
overall survival

研究概览

简要总结

The aim of this study is to establish a selection criteria of hepatectomy for patients with multiple hepatocellular carcinomas based on the NDR Scoring System

详细描述

Multiple hepatocellular carcinomas (HCCs) accounts for 60% to 70% of patients with hepatocellular carcinoma.However,the selection criteria of hepatectomy for patients with multiple HCCs remains controversial.Researches have suggested that part of the patients with multiple HCCs can also benefit from hepatectomy.But,expanding the selection criteria for hepatectomy will increase tumor recurrence rates and reduce the therapeutic effect, more stringent selection criteria will also make part of the patients who should take hepatectomy lose the operation chance. This is a difficult problem in the research of this field.The Barcelona Clinic Liver Cancer (BCLC) system recommends that stage A (number ≤ 3, largest diameter ≤ 3 cm) were suitable for liver resection.However, increasing reports on good outcome after hepatectomy for patients with multiple HCCs have been published.Studies on clonal origin suggest that hepatectomy is a better treatment for multiple HCCs from multicentric origin (MO) than that from intrahepatic metastasis (IM) and the 5-year overall survival rates is 24% to 58%.The investigators established a scoring system(NDR score; N, tumor number; D, total tumor diameter; R, ratio of largest/smallest diameter) based on preoperative data which can accurately predict postoperative long-term survival of patients with multiple HCCs.The formula is as follows: 1×N(N: >3=1; ≤3= 0)+ 2×D(D: >8cm = 1; ≤8cm= 0)+ 1×R(R: >6 = 1; ≤6= 0).The investigators first propose a selection criteria of hepatectomy for patients with multiple HCCs based on this scoring system. Patients with a NDR score 0-2 are recommended for hepatectomy and can benefit from the surgery,and because of the unsatisfied outcome,patients with a NDR score more than 2 are not recommended for hepatectomy.The stringent selection criteria should be expanded so that more patients can benefit from hepatectomy,and the less stringent criteria should be limited to ensure curative effect.So,the investigators' NDR scoring system was more accurate in selecting patients with multiple HCCs for hepatectomy and this article was published on Ann Surg Oncol(2015,22:826).In order to further confirm the rationality of this selection criteria,the investigators would like to propose a prospective randomized controlled study.

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
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Male or female patients > 18 years and <=70 years of age
  • Patients preoperatively diagnosed of hepatocellular carcinoma according to the criteria of American Association for the Study of Liver Diseases(AASLD).
  • Preoperative ECOG criteria score of 0-1
  • Child-Pugh class A liver function
  • Multiple hepatocellular carcinomas with tumor number <=5 and total tumor diameter <=15 cm

排除标准

  • Major portal/hepatic vein invasion
  • Extrahepatic metastasis
  • Patients with apparent cardiac, pulmonary, cerebral and renal dysfunction,which may affect the treatment of liver cancer
  • Anticancer treatment before surgery
  • Lost to follow-up

结局指标

主要结局

overall survival

时间窗: 5 years

次要结局

  • Time to recurrence(5 years)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

ShenFeng

vice president of the Eastern Hepatobiliary Surgery Hospital

Eastern Hepatobiliary Surgery Hospital

研究点 (1)

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