Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.

DC-CIK Immunotherapy Plus Chemotherapy vs Chemotherapy Alone in the Adjuvant Treatment of Stage III Colorectal Cancer

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02415699
Recruitment Status : Not yet recruiting
First Posted : April 14, 2015
Last Update Posted : April 14, 2015
Sponsor:
Information provided by (Responsible Party):
Sixth Affiliated Hospital, Sun Yat-sen University

Tracking Information
First Submitted Date  ICMJE April 9, 2015
First Posted Date  ICMJE April 14, 2015
Last Update Posted Date April 14, 2015
Study Start Date  ICMJE August 2015
Estimated Primary Completion Date July 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 13, 2015)
Disease free survival [ Time Frame: 2 years ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: April 13, 2015)
  • Overall survival [ Time Frame: 2 years ]
  • Side Effect [ Time Frame: 6 month ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE DC-CIK Immunotherapy Plus Chemotherapy vs Chemotherapy Alone in the Adjuvant Treatment of Stage III Colorectal Cancer
Official Title  ICMJE Randomized Controlled Trial Comparing DC-CIK Immunotherapy Combined With Adjuvant Chemotherapy and Adjuvant Chemotherapy Alone in Stage III Colorectal Cancer.
Brief Summary Stage III colorectal cancer constitutes more than half of the colorectal patients, and the prognosis does not improve much recently although varies of adjuvant drugs have been tried. DC-CIK immunotherapy has been proved to improve survival in cancer patients, but its role in stage III colorectal cancer patients stains unclear. The investigators study will focus on the efficacy and safety of DC-CIK immunotherapy plus chemotherapy in the adjuvant treatment of stage III colorectal cancer, compared with chemotherapy alone.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Colorectal Cancer
Intervention  ICMJE
  • Drug: Fluorouracil
    Other Name: 5-FU
  • Drug: Oxaliplatin
  • Drug: Leucovorin
  • Biological: DC-CIK
Study Arms  ICMJE
  • Experimental: DC-CIK Immunotherapy Plus Chemotherapy
    Stage III Colon Cancer patients after radical operation and adjuvant chemotherapy will receive 12 cycles of DC-CIK therapy in this group
    Interventions:
    • Drug: Fluorouracil
    • Drug: Oxaliplatin
    • Drug: Leucovorin
    • Biological: DC-CIK
  • Active Comparator: Chemotherapy Alone
    Stage III Colon Cancer patients after radical operation and adjuvant chemotherapy alone.
    Interventions:
    • Drug: Fluorouracil
    • Drug: Oxaliplatin
    • Drug: Leucovorin
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 Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: April 13, 2015)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2020
Estimated Primary Completion Date July 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Stage III colon cancer
  • Undergone complete resection of primary tumor
  • Completed standard adjuvant chemotherapy
  • ECOG performancer status 0-2
  • Adequate hematologic, hepatic and renal functions

Exclusion Criteria:

  • HIV positive or other Immunodeficiency disease
  • Uncontrolled hypertension
  • History of recent cancers in the past 5 years
  • Patients with previous or concurrent malignancy or any anti-cancer therapy
  • Patients who were allergic to platinum drugs or fluorouracil
  • Pregnant patients
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Xiaojian Wu, MD, PHD 020-38254009 sumswxj@126.com
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02415699
Other Study ID Numbers  ICMJE 2015045010
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sixth Affiliated Hospital, Sun Yat-sen University
Study Sponsor  ICMJE Sixth Affiliated Hospital, Sun Yat-sen University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Sixth Affiliated Hospital, Sun Yat-sen University
Verification Date April 2015

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