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临床试验/NCT04814030
NCT04814030Unknown2 期

Transarterial Infusion of PD-1 Antibody Plus Chemoembolization and FOLFOX-based Chemtherapy for Unresectable BCLC C Stage HCC: a Single-arm, Phase 2 Clinical Trial

Sun Yat-sen University1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2021年4月20日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
发起方
入组人数
80
试验地点
1
主要终点
overall response rate

研究概览

简要总结

Hepatocellular carcinoma (HCC) is a common disease in East Asia. Less than 20% of newly diagnosed patients can undergo radical resection. For those with unresectable BCLC C stage, transarterial chemotherapy and targeted therapy are recommend to prolong survival. Recently, FOLFOX (Oxaliplatin and 5-fluorouracil) based hepatic artery infusion chemotherapy (HAIC) exhibited high response rate for unresectable HCC. Transartery infusion of agents provide promising outcome when compared systemic infusion. Furthermore, our pilot study showed TACE combined HAIC (TACE-HAIC) had better tumor response, with low progression disease rate. Whether TACE-HAIC plus hepatic artery infusion PD-1 antibody would improve survival for unresectalbe BCLC C stage patients is still unknown. A single arm, phase 2 clinical trial is aimed to answer this question.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

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

  • BCLC C stage with unresectable diseasehigh-recurrence risk factor;
  • Child-Pugh A or B (7 score) liver function;
  • Anticipated survival more than 3 moths

排除标准

  • Pregnant woman or sucking period;
  • With other malignant cancer;
  • Received anti-HCC therapy before this study

研究组 & 干预措施

AIPD-1

Experimental

Trans hepatic artery infusion of PD-1 antibody, chemoembolization, FOLFOX-based infusion chemotherapy

干预措施: PD-1 inhibitor (Drug)

结局指标

主要结局

overall response rate

时间窗: 12 month

defined as the sum of complete responses (CRs) and partial responses (PRs) over a specified time period

次要结局

未报告次要终点

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

Yunfei Yuan

Professor

Sun Yat-sen University

研究点 (1)

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