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Cytokine-induced Killer Cell Immunotherapy for Surgical Resected Stage III Colorectal Cancer Patients After Chemotherapy

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ClinicalTrials.gov Identifier: NCT02280278
Recruitment Status : Unknown
Verified November 2014 by Xiao-Jun Wu, Sun Yat-sen University.
Recruitment status was:  Recruiting
First Posted : October 31, 2014
Last Update Posted : November 5, 2014
Sponsor:
Information provided by (Responsible Party):
Xiao-Jun Wu, Sun Yat-sen University

Tracking Information
First Submitted Date  ICMJE October 29, 2014
First Posted Date  ICMJE October 31, 2014
Last Update Posted Date November 5, 2014
Study Start Date  ICMJE October 2014
Estimated Primary Completion Date October 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 29, 2014)
Disease free survival [ Time Frame: 3 years ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02280278 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 3, 2014)
  • survival rate [ Time Frame: 5 years ]
  • toxin-side effect [ Time Frame: 1 year ]
    Toxin-side effect will be assessed by laboratory test, clinicians and questionary
Original Secondary Outcome Measures  ICMJE
 (submitted: October 29, 2014)
  • survival rate [ Time Frame: 5 years ]
  • toxin-side effect [ Time Frame: 1 year ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Cytokine-induced Killer Cell Immunotherapy for Surgical Resected Stage III Colorectal Cancer Patients After Chemotherapy
Official Title  ICMJE The Effectiveness and Safety of Adjuvant Cytokine-induced Killer Cell Immunotherapy for Stage III Colorectal Cancer Patients After Chemotherapy
Brief Summary We hypothesize through this randomized, prospective, single center adjuvant study, that cytokine-induced killer cell in patients with stage III colon cancer can improve survival in this patient population over control. Stage III colon cancer patients can benefit most from adjuvant chemotherapy, but the 5 year survival rate is still around 60%. We wish CIK cell therapy can improve the survival rate of stage III colon cancer patients.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Stage III Colon Cancer
Intervention  ICMJE
  • Procedure: Radical surgery
  • Drug: Adjuvant chemotherapy
  • Biological: Cytokine-induced killer cell immunotherapy
Study Arms  ICMJE
  • Experimental: CIK group
    Stage III Colon Cancer patients after radical operation and adjuvant chemotherapy will receive 8 cycles of CIK therapy in this group.
    Interventions:
    • Procedure: Radical surgery
    • Drug: Adjuvant chemotherapy
    • Biological: Cytokine-induced killer cell immunotherapy
  • Active Comparator: Control group
    Stage III Colon Cancer patients will only receive radical operation and adjuvant chemotherapy.
    Interventions:
    • Procedure: Radical surgery
    • Drug: Adjuvant chemotherapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: October 29, 2014)
550
Original Estimated Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Estimated Primary Completion Date October 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male or female outpatient of ≥ 18 years of age or ≥ country's legal age for adult consent
  • Stage III colon cancer
  • undergone complete resection of primary tumor
  • Completed standard adjuvant chemotherapy
  • within 120 days of completion of standard therapy
  • ECOG performancer status 0-2
  • Satisfactory haematological or biochemical functions (tests should be carried out within 8 weeks prior to randomisation): Results of clinical investigations carried out within 8 weeks prior to randomisation can be used in place of the required screening investigations. Patients with mild laboratory abnormalities can be included at the discretion by the site principal investigator, and after approval by ASCOLT Trial Management Group
  • ANC ≥ 1.0 x 109/L
  • Platelets ≥ 100 x 109/L
  • Creatinine clearance ≥ 30 mL/min
  • Total bilirubin ≤ 2.0 x the upper limit normal
  • AST & ALT ≤ 5 x the upper limit normal
  • Completed the following investigations
  • Completed the following investigations

Exclusion Criteria:

  • HIV positive or other Immunodeficiency disease
  • recently use of high dose glucocorticoid
  • Uncontrolled hypertension (untreated systolic blood pressure > 160 mmHg, or diastolic blood pressure > 95 mmHg)
  • History of recent cancers (except for colorectal cancers, non-melanoma skin cancers, basal cell carcinomas, squamous cell carcinomas) in the past 5 years
  • Patient having known allergy to capecitabine or Oxaliplatin
  • Pregnant, lactating
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02280278
Other Study ID Numbers  ICMJE 5010010
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Xiao-Jun Wu, Sun Yat-sen University
Study Sponsor  ICMJE Sun Yat-sen University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Xiao-Jun Wu, Prof. Sun Yat-sen University
PRS Account Sun Yat-sen University
Verification Date November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP