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临床试验/NCT03914352
NCT03914352Unknown不适用

A Novel Immunotherapy PD-1 Antiboty to Suppress Recurrence of Hepatocellular Carcinoma Combined With Portal Vein Thrombus After Hepatic Resection

Cancer Hospital of Guangxi Medical University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2019年4月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
发起方
入组人数
40
试验地点
1
主要终点
Disease-free survival

研究概览

简要总结

Hepatic resection is the most effective curative treatment for resectable HCC, whereas frequent recurrence usually impaired the efficacy of hepatic resection and contributed poor survivals. PVTT has been certified as an independent risk of early recurrence.

Although TACE has been used to decrease the intraheptic recurrence. However, the intraheptic recurrence rate remains high and meanwhile it is uncapable to suppress extrahepatic recurrence. In addition, systematic therapy the small molecular target antiangiogenesis medicine sorafenib were used to prevent recurrence. Unfortunately, the STORM trial shows that postoperative antiangiogenesis therapy was failed to suppress recurrence and prolong survival period for HCC patients. Thus, novel effective systematic therapy to suppress postoperative recurrence is in urgent need.

At present, the PD-1 antibody has presented a promising and safe therapeutic result of unresectable HCC and provided good survival benefit for advanced HCC patients. Consistent with this, we proposed a hypothesis that a novel immunetherapy using the PD-1 antibody could suppress postoperative recurrence and prolong HCC patients survival period effectively.

详细描述

Hepatic resection is the most effective curative treatment for resectable hepatocellular carcinoma (HCC), whereas frequent recurrence usually impaired the efficacy of hepatic resection and contributed poor survivals. Portal vein tumor thrombus (PVTT) has been certified as an independent risk of early recurrence (≤2years after hepatic resection).

Although Transarterial Chemoembolization (TACE) has been used as an effective local adjuvant treatment to decrease the intraheptic recurrence. However, the intraheptic recurrence rate remains high and meanwhile it is uncapable to suppress extrahepatic recurrence. In addition, systematic therapy the small molecular target antiangiogenesis medicine sorafenib were used to prevent recurrence. Unfortunately, the double blind randomized STORM trial shows a negative result that postoperative antiangiogenesis therapy was failed to suppress recurrence and prolong survival period for HCC patients. Thus, novel effective systematic therapy to suppress postoperative recurrence is in urgent need.

At present, the PD-1 antibody has presented a promising and safe therapeutic result of unresectable HCC and provided good survival benefit for advanced HCC patients. Consistent with this, we proposed a hypothesis that a novel immunetherapy using the PD-1 antibody could suppress postoperative recurrence and prolong HCC patients survival period effectively.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Care Provider)

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

  • HCC comfirmed by postoperative histology examination
  • PVTT comfirmed by postoperative histology examination
  • None other type of malignant tumors
  • None intra or extra-hepatic recurrence postoperative adjuvant therapy
  • Child-pugh grade A or B liver function
  • None other organ dysfunction

排除标准

  • Combined with other type of malignant tumors
  • Presence of intra or extra-hepatic recurrence
  • Child-pugh grade C liver function
  • Combined with other organ dysfunction

研究组 & 干预措施

PD-1 antibody group

Experimental

In this group participants were treated with PD-1 antibody (240mg, Intravenous drip infusion, Q14 days) since the15 days after hepatic resection and at the interval of 15 days.

干预措施: PD-1 antibody (Drug)

Controlled group

Active Comparator

In this group entrolled patients were treated with TACE in the 30 days after hepatic resection.

干预措施: TACE (Procedure)

结局指标

主要结局

Disease-free survival

时间窗: 5 years

Cumulative none recurrence survival period after hepatic resection

Overall survival

时间窗: 5 years

Cumulative survival period after hepatic resection

次要结局

未报告次要终点

研究者

发起方
Cancer Hospital of Guangxi Medical University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Jia-zhou Ye

Principal investigator

Cancer Hospital of Guangxi Medical University

研究点 (1)

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