NCT02987907Unknown3 期
The Impact on Therapeutic Effect and Tolerance of Treatment for Patients With Hepatocellular Carcinoma in Transcatheter Arterial Chemoembolization (TACE) of Dexamethasone Application: A Random, Double-blind, Controlled, Clinical Trial.
Sun Yat-sen University1 个研究点 分布在 1 个国家目标入组 220 人开始时间: 2016年8月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 220
- 试验地点
- 1
- 主要终点
- response rate (RR)
研究概览
简要总结
The current random, double-blind, controlled, clinical trial was designed to evaluate the impact on therapeutic effect and tolerance of treatment for patients with hepatocelluclar carcinoma in transcatheter arterial chemoembolization (TACE) of dexamethasone application.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •older than 18 years old;
- •ECOG PS<3;
- •proven hepatocellular carcinoma according patological examination or EASL/AASLD diagnostic criteria;
- •meeting at least 1/4: 1) multiple nodules, 2) single tumor but not suitable for resection, 3) vascular invasion exists, 4) distant metastasis excluding CNS and bone
- •not previous treated for tumor;
- •Child-Pugh A or B;
- •at least one measurable lesion according mRECIST;
- •cannot afford sorafenib;
- •the lab test could meet: neutrophil count≥1.5×109/L; hemoglobin≥80g/L; platelet count≥60×109/L; serum albumin≥28g/L; total bilirubin<3-times upper limit of normal; ALT<5-times upper limit of normal; AST<5-times upper limit of normal; serum creatine<1.5-times upper limit of normal; PT≤upper limit of normal plus 6 seconds; INR≤2.3
- •sign up consent;
- •unrolled by other clinical trials about hepatocellular carcinoma.
排除标准
- •cannot tolerate TACE;
- •CNS or bone metastasis exits;
- •known history of other malignancy;
- •be allergic to related drugs;
- •underwent organ transplantation before;
- •be treated before (interferon included);
- •known history of HIV infection;
- •known history of drug or alcohol abuse;
- •have GI hemorrage or cardiac/brain vascular events within 30 days;
- •pregnancy;
研究组 & 干预措施
treatment group
Experimental
use dexamethasone 10mg (2ml) I.A. during TACE
干预措施: Dexamethasone (Drug)
control group
Placebo Comparator
use normal saline 2ml I.A. during TACE
干预措施: Normal Saline (Drug)
结局指标
主要结局
response rate (RR)
时间窗: 1 month after TACE
proportions of participants with severe adverse events according to CTCAE v4.03
时间窗: 1 month after TACE
次要结局
- progression-free survival (PFS)(From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months)
- overall survival (OS)(From date of randomization until the date of death from any cause, assessed up to 60 months)
- time to progression (TTP)(From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months)
研究者
Li Shaohua
Attending Doctor, Department of Hepatobiliary Pancreatic Surgery
Sun Yat-sen University
研究点 (1)
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