JPRN-jRCTs041180176已完成2 期
Randomized phase II study exploring better regimen of hepatic arterial infusion chemotherapy (HAIC) for the patients with advanced hepatocellular carcinoma
Kaneko Shuichi0 个研究点目标入组 33 人开始时间: 2019年3月29日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 33
研究概览
简要总结
This study, which designed to determine a useful regimen of HAIC in patients with advanced HCC who are refractory to or ineligible for standard of care, showed that PFS was statistically significantly better in FP regimen compared to CDDP regimen. The results of this study suggested that the FP regimen was beneficial compared to CDDP regimen although it is difficult to draw a clear conclusion because the number of scheduled could not be registered.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 ot applicable（—）
- 性别
- All
入选标准
- •clinically diagnosed as hepatocellular carcinoma; presence of intrahepatic lesion; unsuitable for local therapy; unsuitable for standard therapy including sorafenib; Child-Pugh score <=8; ECOG Performance status <=2; preservation of major organ function; written informed consent
排除标准
- •technically unsuitable for HAIC; extrahepatic lesion; refractory ascites or pleural effusion, history of hepatic encephalopathy, risky varices; double cancer; metastases to central nervous system; severe complication; pregnant or lactating women, or women of childbearing potential; mental disorder; allergy for fluorouracil, cisplatin, or contrast agent of CT or/and MRI
研究者
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