Clinical Research Papers:
Effectiveness and safety of sorafenib in the treatment of unresectable and advanced intrahepatic cholangiocarcinoma: a pilot study
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Xiangji Luo1, Weidong Jia2, Zhiyong Huang3, Xiangcheng Li4, Baocai Xing5, Xiaoqing Jiang1, Jun Li6, Anfeng Si6, Tian Yang6, Chunfang Gao7, Wan Yee Lau6,8 and Feng Shen6
1 Department of Biliary Surgery, The Eastern Hepatobiliary Surgery Hospital, Second Military Medical University, Shanghai, China
2 Department of Hepatobiliary Surgery, The Anhui Provincial Hospital, Hefei, China
3 Department of Hepatobiliary Surgery, The Tongji Hospital, Huazhong University of Science and Technology, Wuhan, China
4 Department of Hepatobiliary Surgery, The Jiangsu Provincial People’s Hospital, Nanjing, China
5 Department of Hepatobiliary Surgery, The Beijing Cancer Hospital, Beijing, China
6 Department of Hepatic Surgery, The Eastern Hepatobiliary Surgery Hospital, Second Military Medical University, Shanghai, China
7 Department of Laboratory Diagnosis, The Eastern Hepatobiliary Surgery Hospital, Second Military Medical University, Shanghai, China
8 Faculty of Medicine, The Chinese University of Hong Kong, Shatin, Hong Kong, SAR, China
Feng Shen, email:
Keywords: intrahepatic cholangiocarcinoma; sorafenib; adverse events; disease control rate
Received: April 12, 2016 Accepted: October 14, 2016 Published: October 23, 2016
Patients with unresectable and advanced intrahepatic cholangiocarcinoma (ICC) usually have short survival due to a lack of effective treatment. This multicenter, single arm, open labeled, prospective study was conducted to evaluate the effectiveness and safety of sorafenib combined with best supportive care (BSC) in these patients. We enrolled 44 patients with unresectable and advanced ICC who were treated with sorafenib (400 mg, twice daily) and BSC. The primary endpoint was disease control rate (DCR) at week 12, and the secondary endpoints included time to progression (TTP), progression-free survival (PFS), overall survival (OS), duration of therapy (DOT), and adverse events (AEs). Our results showed that the DCR was 15.9%, the median TTP was 5.6 months, and the median PFS and OS were 3.2 and 5.7 months (95% confidence interval [CI]: 2.4-4.1 months; 3.7-8.5 months), respectively. The median DOT was 1.8 months (95% CI: 1.9-3.9 months). AEs of grades 1 and 2 events occurred in 75% of patients, and AE of grade 4 (severe) was observed in 1 patient. Therefore, sorafenib in combination with BSC had an acceptable DCR and safety profile in patients with unresectable and advanced ICC.
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