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临床试验/NCT02956772
NCT02956772Unknown2 期

A Prospective Multicenter Randomized Controlled Open-label Trial of Transcatheter Arterial Chemoembolization (TACE) in Combination With Arsenic Trioxide Versus TACE in the Treatment of Middle-advanced Primary Hepatocellular Carcinoma (HCC) Patients

Hunan Provincial People's Hospital9 个研究点 分布在 1 个国家目标入组 190 人开始时间: 2016年11月最近更新:
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
190
试验地点
9
主要终点
Progression free survival

研究概览

简要总结

A multicentre, randomized, open-label, parallel-group, active controlled study.

详细描述

Primary hepatocellular carcinoma (HCC) is one of the most common types of cancer and accounts for significant morbidity and mortality worldwide. Notably, more than half of the new HCC cases and deaths develop in China. Transarterial chemoembolization (TACE) has been proposed as the first-line therapeutic strategy for the treatment of patients with unresectable HCC. However, TACE has several limitations itself which might be potentially associated with tumor metastasis and relapse.

Recent studies have demonstrated that arsenic trioxide (As2O3) can act as the first-line therapeutic option in the treatment of acute promyelocytic leukemia. Thereafter, several small studies in China showed promising clinical benefits when As2O3 is administrated among the HCC patients. With these preliminary results, the investigators are planning to carry out a multicenter randomized controlled trial through which to explore the potential efficacy and safety of adjuvant As2O3 treatment for HCC patients.

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
None

入排标准

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

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

TACE plus Arsenic Trioxide

Experimental

Patients in this group are to receive a single dose of TACE treatment on day 1, followed by arsenic trioxide at 10 mg/day for 14 days (day 8-21). TACE treatment is repeated every 9 weeks while arsenic trioxide every 3 weeks for treatment duration of 27 weeks. At least 3 cycles of arsenic trioxide are administrated.

干预措施: TACE (Drug)

TACE plus Arsenic Trioxide

Experimental

Patients in this group are to receive a single dose of TACE treatment on day 1, followed by arsenic trioxide at 10 mg/day for 14 days (day 8-21). TACE treatment is repeated every 9 weeks while arsenic trioxide every 3 weeks for treatment duration of 27 weeks. At least 3 cycles of arsenic trioxide are administrated.

干预措施: Arsenic trioxide (Drug)

TACE

Active Comparator

Patients in this group are to receive a single dose of TACE treatment on day 1. TACE treatment is repeated every 9 weeks for 27 weeks.

干预措施: TACE (Drug)

结局指标

主要结局

Progression free survival

时间窗: 2-year

Progression free survival (PFS) is defined as the time interval from the day of the random assignment to the first evidence of progression or death.

次要结局

  • Incidence of adverse events(Up to 2 years through study completion)
  • Overall Survival(2-year)
  • Objective response rate(2-year)

研究者

发起方
Hunan Provincial People's Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Xiang Hua

Dr.

Hunan Provincial People's Hospital

研究点 (9)

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