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索拉非尼联合间歇性肝动脉灌注化疗治疗不可切除肝细胞癌的I期研究

Phase I Study of Sorafenib in Combination with Intermittent Hepatic Arterial Infusion Chemotherapy for Unresectable Hepatocellular Carcinoma.

作者信息

Ishizaki Morihiko, Kaibori Masaki, Matsui Kosuke, Ikeda Hiroki, Yoshida Katsunori, Okazaki Kazuichi, Kariya Syuji, Tanigawa Noboru, Nakatake Richi, Matsushima Hideyuki, Sakaguchi Tatsuma, Kon Masanori

机构信息

a Department of Surgery , Kansai Medical University , Osaka , Japan.

b Department of Gastroenterology and Hepatology , Kansai Medical University , Osaka , Japan.

出版信息

Cancer Invest. 2017 Apr 21;35(4):271-276. doi: 10.1080/07357907.2017.1289382. Epub 2017 Mar 8.

DOI:10.1080/07357907.2017.1289382
PMID:28272913
Abstract

OBJECTIVES

We conducted a phase I study of sorafenib and intermittent hepatic arterial infusion chemotherapy using cisplatin for unresectable hepatocellular carcinoma.

METHODS

Sorafenib was administered continuously, whereas cisplatin was administered once every 3 weeks. We estimated the safety and efficacy.

RESULTS

Fifteen patients were enrolled into this study. The dose-limiting toxicities occurred at sorafenib 800 mg and cisplatin 20 mg/m. The recommended dose was at sorafenib 400 mg and cisplatin 30 mg/m. The disease control rate was 73.3%.

CONCLUSIONS

This treatment is feasible for unresectable hepatocellular carcinoma. Further evaluation of the regimen in a randomized controlled trial is warranted.

摘要

目的

我们开展了一项索拉非尼联合顺铂间歇性肝动脉灌注化疗用于不可切除肝细胞癌的I期研究。

方法

索拉非尼持续给药,而顺铂每3周给药一次。我们评估了安全性和疗效。

结果

15名患者入组本研究。剂量限制性毒性出现在索拉非尼800毫克和顺铂20毫克/平方米时。推荐剂量为索拉非尼400毫克和顺铂30毫克/平方米。疾病控制率为73.3%。

结论

这种治疗方法对不可切除的肝细胞癌是可行的。有必要在随机对照试验中对该方案进行进一步评估。

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