title: Phase II/III Study of Radiofrequency Ablation Combined with Cytokine-Induced Killer Cells Treating Colorectal Liver Metastases.
abstract: OBJECTIVE
  This phase II/III, non-randomized clinical trial aimed to determine the efficacy and safety of the combination of radiofrequency ablation (RFA) and cytokine-induced killer (CIK) cells transfusion for patients with colorectal liver metastases (CRLMs).
  
  
  METHODS
  A total of 60 eligible patients with CRLMs were enrolled and divided into Group A (RFA alone, n = 30) and Group B (RFA plus CIK, n = 30), and following enzyme-linked immunosorbent spot assay was performed in 8 patients with CEA > 50 ng/mL pre-RFA and 7 days post-RFA and CIK treatment, respectively.
  
  
  RESULTS
  The median progression-free survival (PFS) times of Group A and Group B were 18.5 months and 23 months, respectively (P = 0.0336). The 3-year progression-free rates were 13.3% in Group A and 20.3% in Group B, respectively. The median overall survival time was 43 months in Group A, and not reached in Group B. The 3-year survival rates were 64.6% in Group A and 81.0% in Group B, respectively (P = 0.1187). Among the 8 patients with CEA > 50ng/mL, 6 had increase of circulating CEA-specific T cells after RFA (P = 0.010). After CIK cell therapy, the number of CEA-specific T cells increased in all the 8 patients comparing with that pre-treatment (P = 0.001) and in 7 patients comparing with that post-RFA (P = 0.028).
  
  
  CONCLUSIONS
  We firstly confirm that the combination of RFA and CIK cells boosts CEA-specific T cell response and shows to be an efficacious and safe treatment modality for patients with CRLMs.
authors.affiliation: Department of Oncology, The Third Affiliated Hospital of Soochow University, Changzhou, China.
authors.forename: Xiaodong
authors.initials: X
authors.lastname: Li
authors.forename: Xichao
authors.initials: X
authors.lastname: Dai
authors.forename: Liangrong
authors.initials: L
authors.lastname: Shi
authors.forename: Yong
authors.initials: Y
authors.lastname: Jiang
authors.forename: Xuemin
authors.initials: X
authors.lastname: Chen
authors.forename: Lujun
authors.initials: L
authors.lastname: Chen
authors.forename: Jiemin
authors.initials: J
authors.lastname: Zhao
authors.forename: Weiguang
authors.initials: W
authors.lastname: Qiang
authors.forename: Jun
authors.initials: J
authors.lastname: Wu
authors.forename: Mei
authors.initials: M
authors.lastname: Ji
authors.forename: Jingting
authors.initials: J
authors.lastname: Jiang
authors.forename: Changping
authors.initials: C
authors.lastname: Wu
mesh_terms: D000328:Adult; D000368:Aged; D017115:Catheter Ablation / Q000009:adverse effects; D015179:Colorectal Neoplasms / Q000473:pathology*; D003131:Combined Modality Therapy; D055612:Cytokine-Induced Killer Cells / Q000276:immunology*; D018572:Disease-Free Survival; D058501:Enzyme-Linked Immunospot Assay; D005260:Female; D006801:Humans; D008113:Liver Neoplasms / Q000000981:diagnostic imaging / Q000276:immunology / Q000556:secondary* / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D014057:Tomography, X-Ray Computed