title: A randomized controlled trial on patients with or without adjuvant autologous cytokine-induced killer cells after curative resection for hepatocellular carcinoma.
abstract: There is no generally accepted adjuvant therapy for hepatocellular carcinoma (HCC) after curative resection. Autologous cytokine-induced killer (CIK) cells therapy has been reported to improve outcomes of patients with HCC, but its role as an adjuvant therapy remains unclear. This study aimed to evaluate the efficacy and safety of CIK as an adjuvant therapy for HCC after curative resection.
  
  
  
  This is a single center, phase 3, open label, randomized controlled trial (RCT). Two hundred patients who were initially diagnosed with HCC of Barcelona Clinic Liver Cancer (BCLC) stage A or B, and underwent curative hepatectomy were randomly assigned to receive four cycles of CIK treatment (the CIK group, n = 100) or no treatment (the control group, n = 100). The primary outcome was time to recurrence. The secondary outcomes included disease-free survival (DFS), overall survival (OS) and adverse events.
  
  
  
  All patients in the CIK group finished the treatment by protocol. The median time to recurrence (TTR) was 13.6 (IQR 6.5-25.2) mo in the CIK group and 7.8 (IQR 2.7-17.0) mo in the control group (p= 0.01). There were no significant differences between the groups in DFS and OS. All adverse events were grade 1 or 2. There were no significant differences in incidence between the two groups.
  
  
  
  Four cycles of CIK therapy were safe and effective to prolong the median TTR in patients with HCC after curative resection, but the treatment did not improve the DFS and OS.
authors.affiliation: Department of Hepatobiliary Surgery, Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, China; State Key Laboratory of Oncology in Southern China, Guangzhou, Guangdong, China; Collaborative Innovation Center for Cancer Medicine, Guangzhou, Guangdong, China; Department of Surgery, The Johns Hopkins University School of Medicine, Baltimore, MD, USA.
authors.forename: Li
authors.initials: L
authors.lastname: Xu
authors.affiliation: Department of Hepatobiliary Surgery, Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, China; State Key Laboratory of Oncology in Southern China, Guangzhou, Guangdong, China; Collaborative Innovation Center for Cancer Medicine, Guangzhou, Guangdong, China; Department of Ultrasound, Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, China.
authors.forename: Jun
authors.initials: J
authors.lastname: Wang
authors.affiliation: Department of Surgery, The Johns Hopkins University School of Medicine , Baltimore, MD, USA.
authors.forename: Yuhree
authors.initials: Y
authors.lastname: Kim
authors.affiliation: Department of Hepatobiliary Surgery, Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, China; State Key Laboratory of Oncology in Southern China, Guangzhou, Guangdong, China; Collaborative Innovation Center for Cancer Medicine, Guangzhou, Guangdong, China.
authors.forename: Ze-Yu
authors.initials: ZY
authors.lastname: Shuang
authors.affiliation: Department of Hepatobiliary Surgery, Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, China; State Key Laboratory of Oncology in Southern China, Guangzhou, Guangdong, China; Collaborative Innovation Center for Cancer Medicine, Guangzhou, Guangdong, China.
authors.forename: Yao-Jun
authors.initials: YJ
authors.lastname: Zhang
authors.affiliation: Department of Hepatobiliary Surgery, Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, China; State Key Laboratory of Oncology in Southern China, Guangzhou, Guangdong, China; Collaborative Innovation Center for Cancer Medicine, Guangzhou, Guangdong, China.
authors.forename: Xiang-Ming
authors.initials: XM
authors.lastname: Lao
authors.affiliation: State Key Laboratory of Oncology in Southern China, Guangzhou, Guangdong, China; Collaborative Innovation Center for Cancer Medicine, Guangzhou, Guangdong, China; Department of Biotherapy, Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, China.
authors.forename: Yong-Qiang
authors.initials: YQ
authors.lastname: Li
authors.affiliation: Department of Hepatobiliary Surgery, Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, China; State Key Laboratory of Oncology in Southern China, Guangzhou, Guangdong, China; Collaborative Innovation Center for Cancer Medicine, Guangzhou, Guangdong, China.
authors.forename: Min-Shan
authors.initials: MS
authors.lastname: Chen
authors.affiliation: Department of Surgery, The Johns Hopkins University School of Medicine , Baltimore, MD, USA.
authors.forename: Timothy M
authors.initials: TM
authors.lastname: Pawlik
authors.affiliation: State Key Laboratory of Oncology in Southern China, Guangzhou, Guangdong, China; Collaborative Innovation Center for Cancer Medicine, Guangzhou, Guangdong, China; Department of Biotherapy, Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, China.
authors.forename: Jian-Chuan
authors.initials: JC
authors.lastname: Xia
authors.affiliation: Department of Hepatobiliary Surgery, Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, China; State Key Laboratory of Oncology in Southern China, Guangzhou, Guangdong, China; Collaborative Innovation Center for Cancer Medicine, Guangzhou, Guangdong, China.
authors.forename: Sheng-Ping
authors.initials: SP
authors.lastname: Li
authors.affiliation: Faculty of Medicine, The Chinese University of Hong Kong Prince of Wales Hospital , Hong Kong S.A.R., China.
authors.forename: Wan-Yee
authors.initials: WY
authors.lastname: Lau
keywords: Adjuvant therapy; cytokine-induced killer cells; hepatocellular carcinoma; recurrence; surgery