Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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: NCT02280278
Recruitment Status : 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

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.

Condition or disease Intervention/treatment Phase
Stage III Colon Cancer Procedure: Radical surgery Drug: Adjuvant chemotherapy Biological: Cytokine-induced killer cell immunotherapy Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 550 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effectiveness and Safety of Adjuvant Cytokine-induced Killer Cell Immunotherapy for Stage III Colorectal Cancer Patients After Chemotherapy
Study Start Date : October 2014
Estimated Primary Completion Date : October 2019

Arm Intervention/treatment
Experimental: CIK group
Stage III Colon Cancer patients after radical operation and adjuvant chemotherapy will receive 8 cycles of CIK therapy in this group.
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.
Procedure: Radical surgery
Drug: Adjuvant chemotherapy



Primary Outcome Measures :
  1. Disease free survival [ Time Frame: 3 years ]

Secondary Outcome Measures :
  1. survival rate [ Time Frame: 5 years ]
  2. toxin-side effect [ Time Frame: 1 year ]
    Toxin-side effect will be assessed by laboratory test, clinicians and questionary



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02280278


Contacts
Layout table for location contacts
Contact: Xiao-Jun Wu, Prof. +86 20 87343456 wuxj@sysucc.org.cn
Contact: De-Sen Wan, Prof. +86 20 87343456 wands@sysucc.org.cn

Locations
Layout table for location information
China, Guangdong
Sun Yat-Sen University Cancer Center Recruiting
Guagzhou, Guangdong, China, 510060
Contact: Rong-Xin Zhang, Doc.    +86 20 87343456    zhangrx@sysucc.org.cn   
Contact: Xiao-Shi Zhang, Doc.    +86 20 87343456    zhangxs@sysucc.org.cn   
Principal Investigator: Xiao-Jun Wu, Prof.         
Sub-Investigator: Rong-Xin Zhang, Doc.         
Sub-Investigator: Zhi-Zhong Pan, Prof.         
Sub-Investigator: Xiao-Shi Zhang, Prof.         
Sub-Investigator: Jian-Chuan Xia, Prof.         
Sub-Investigator: Dan-Dan Li, Doc.         
Sub-Investigator: Gong Chen, Prof.         
Sub-Investigator: Zhen-Hai Lu, Prof.         
Sub-Investigator: Yu-Jing Fang, Prof.         
Sub-Investigator: Li-Heng Kong, Doc.         
Sub-Investigator: Jun-Zhong Lin, Doc.         
Sponsors and Collaborators
Sun Yat-sen University
Investigators
Layout table for investigator information
Principal Investigator: Xiao-Jun Wu, Prof. Sun Yat-sen University

Layout table for additonal information
Responsible Party: Xiao-Jun Wu, Professor, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT02280278     History of Changes
Other Study ID Numbers: 5010010
First Posted: October 31, 2014    Key Record Dates
Last Update Posted: November 5, 2014
Last Verified: November 2014
Keywords provided by Xiao-Jun Wu, Sun Yat-sen University:
colon cancer
cytokine-induced killer cell immunotherapy
Additional relevant MeSH terms:
Layout table for MeSH terms
Colonic Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Colonic Diseases
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Immunologic Factors
Physiological Effects of Drugs