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Efficacy of Adjuvant Cytokine-induced Killer Cells in Colon Cancer (CIKCC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01929499
Recruitment Status : Unknown
Verified August 2013 by Yanjuan Zhu, Guangdong Provincial Hospital of Traditional Chinese Medicine.
Recruitment status was:  Not yet recruiting
First Posted : August 28, 2013
Last Update Posted : August 29, 2013
Sponsor:
Information provided by (Responsible Party):
Yanjuan Zhu, Guangdong Provincial Hospital of Traditional Chinese Medicine

Tracking Information
First Submitted Date  ICMJE August 20, 2013
First Posted Date  ICMJE August 28, 2013
Last Update Posted Date August 29, 2013
Study Start Date  ICMJE September 2013
Estimated Primary Completion Date August 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 21, 2013)
DFS (Disease free survival) [ Time Frame: Time elapsedelapsed from the date of surgery to either the date of recurrence or the date of last follow-up information,whichever come first, assessed up to 5 years. ]
Patients who were recurrence free at the end of study or lost to follow-up were censored
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 27, 2013)
  • OS (overall survival) [ Time Frame: Time elapsed from the date of surgery to either the date of death or the date of last follow-up information, whichever came first, assessed up to 5 years. ]
    Patients who were survival at the end of study or lost to follow-up were censored
  • Side effect [ Time Frame: Up to 2 years ]
    Any undesirable secondary effect which occurs in addition to the desired therapeutic effect of CIK or chemotherapy, during the period from the first cycle of chemotherapy or CIK infusion to the end of study. The side effects were described according to the NCI-CTCAE (National Cancer Institute-Common Terminology Criteria for Adverse Events)
  • T lymphocyte subset [ Time Frame: Up to 6 months ]
    During the period of CIK infusion
  • QoL (quality of life) [ Time Frame: Up to 1 year ]
    During the period of chemotherapy and CIK infusion
Original Secondary Outcome Measures  ICMJE
 (submitted: August 21, 2013)
  • OS (overall survival) [ Time Frame: Time elapsed from the date of surgery to either the date of death or the date of last follow-up information, whichever came first, assessed up to 5 years. ]
    Patients who were survival at the end of study or lost to follow-up were censored
  • Side effect [ Time Frame: Up to 2 years ]
    Any side effect happened during the period from the first cycle of chemotherapy or CIK infusion to the end of study
  • T lymphocyte subset [ Time Frame: Up to 6 months ]
    During the period of CIK infusion
  • QoL (quality of life) [ Time Frame: Up to 1 year ]
    During the period of chemotherapy and CIK infusion
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy of Adjuvant Cytokine-induced Killer Cells in Colon Cancer
Official Title  ICMJE Efficacy of Adjuvant Immunotherapy With Cytokine-induced Killer Cells in Patients With Stage II/III Colon Cancer
Brief Summary

It has been reported that the immune status of patients with cancer were suppressed, especially those after surgery and adjuvant chemotherapy. Thus, immunotherapy may decrease the recurrence rate after surgery. CIK cells transfusion has been reported as an effect therapy in advanced cancers. In another retrospective study, investigators found that adjuvant CIK therapy would prolong the disease-free survival (DFS) for colorectal cancer patients.

The purpose of this study is to determine wether adjuvant immunotherapy with CIK cells in patients with colon cancer after operation will prolong DFS, and overall survival (OS).

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Colonic Neoplasms
Intervention  ICMJE Biological: cytokine-induced killer cells
Other Names:
  • CIK
  • cytokine induced killer cells
Study Arms  ICMJE
  • Experimental: synchronous CIK group

    After colectomy, patients will accept chemotherapy combined with cytokine-induced killer cells (CIK) therapy synchronously for 6 months.

    For CapeOx regimen:

    3×109 CIK cells on days 1-3; Oxaliplatin 130mg/m2 on day 7; Capecitabine 1000mg/m2 twice daily on days 7-20; Repeat every 3 weeks for 6-8 cycles.

    For mFolfox6 regimen:

    Oxaliplatin 85mg/m2 IV over 2 hours on day 1; Leucovorin 400mg/m2 IV over 2 hours on day 1; 5-FU 400mg/m2 IV bolus on day 1, then 2400mg/m2 IV continuous infusion over 46-48 hous; 3×109 CIK cells on days 9-11; Oxaliplatin 85mg/m2 IV over 2 hours on day 15; Leucovorin 400mg/m2 IV over 2 hours on day 15; 5-fluorouracil (5-FU) 400mg/m2 IV bolus on day 15, then 2400mg/m2 IV continuous infusion over 46-48 hours; Repeat every 4 weeks for 5-6 cycles.

    Intervention: Biological: cytokine-induced killer cells
  • Experimental: sequence CIK group
    After colectomy, patients will accept adjuvant chemotherapy for 6 months, that is 6-8 cycles of CapeOX regimens (the same as those in arm A), or 10-12 cycles of mFolfox6 regimens(the same as those in arm A), followed by 6-8 cycles of cytokine-induced killer cells (CIK) therapy at least 2 weeks later.
    Intervention: Biological: cytokine-induced killer cells
  • No Intervention: control group
    After colectomy, patients will accept adjuvant chemotherapy for 6 months, that is 6-8 cycles of CapeOX regimens (the same as those in arm A), or 10-12 cycles of mFolfox6 regimens (the same as those in arm A).
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: August 21, 2013)
210
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 2019
Estimated Primary Completion Date August 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Colon cancer in stage III or stage II with high risk after R0 resection
  • Eastern Cooperative Oncology Group (ECOG) performance status was 0 - 1;
  • Life expectancy of at least 3 months;
  • Normal bone marrow, liver, renal, heart and lung function;
  • Age between 18-80;
  • Patients who provided written informed consent for this study

Exclusion Criteria:

  • With uncontrolled other malignant tumors;
  • With uncontrolled infection or tubercle bacillus (TB) or underlying diseases that were severe or life threatening;
  • Patients who need to treat with radiotherapy;
  • Patients who accepted other immunotherapy
  • With sever mental disease or disease with central nervous system (CNS);
  • With the history of organ transplantation, including bone marrow transplantation or stem cell transplantation;
  • Patients with auto immune diseases;
  • pregnant or lactating.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 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 NCT01929499
Other Study ID Numbers  ICMJE CIKCC
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Yanjuan Zhu, Guangdong Provincial Hospital of Traditional Chinese Medicine
Study Sponsor  ICMJE Yanjuan Zhu
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Haibo Zhang, MD Guangdong Provincial Hospital of Chinese Medicine, China
PRS Account Guangdong Provincial Hospital of Traditional Chinese Medicine
Verification Date August 2013

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