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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified August 2013 by Guangdong Provincial Hospital of Traditional Chinese Medicine
Sponsor:
Information provided by (Responsible Party):
Yanjuan Zhu, Guangdong Provincial Hospital of Traditional Chinese Medicine
ClinicalTrials.gov Identifier:
NCT01929499
First received: August 20, 2013
Last updated: August 27, 2013
Last verified: August 2013
  Purpose

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).


Condition Intervention Phase
Colonic Neoplasms
Biological: cytokine-induced killer cells
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Efficacy of Adjuvant Immunotherapy With Cytokine-induced Killer Cells in Patients With Stage II/III Colon Cancer

Resource links provided by NLM:


Further study details as provided by Guangdong Provincial Hospital of Traditional Chinese Medicine:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
    Patients who were recurrence free at the end of study or lost to follow-up were censored


Secondary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
    Patients who were survival at the end of study or lost to follow-up were censored

  • Side effect [ Time Frame: Up to 2 years ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    During the period of CIK infusion

  • QoL (quality of life) [ Time Frame: Up to 1 year ] [ Designated as safety issue: No ]
    During the period of chemotherapy and CIK infusion


Estimated Enrollment: 210
Study Start Date: September 2013
Estimated Study Completion Date: August 2019
Estimated Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

Biological: cytokine-induced killer cells
Other Names:
  • CIK
  • 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.
Biological: cytokine-induced killer cells
Other Names:
  • CIK
  • 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).

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01929499

Contacts
Contact: Yanjuan Zhu (+86)13902260217 zyjsophy@hotmail.com
Contact: Haibo Zhang, MD (+86)13724123615 haibozh@aliyun.com

Locations
China, Guangdong
Guangdong Provincial Hospital of Chinese Medicine Not yet recruiting
Guangzhou, Guangdong, China, 510120
Contact: Yanjuan Zhu    (+86)13902260217    zyjsophy@hotmail.com   
Contact: Haibo Zhang    (+86)13724123615    haibozh@aliyun.com   
Principal Investigator: Haibo Zhang, MD         
Sub-Investigator: Yanjuan Zhu         
Sub-Investigator: Yong Li         
Sub-Investigator: Jianping Bai         
Sub-Investigator: Lirong Liu         
Sub-Investigator: Yihong Liu         
Sub-Investigator: Yanchun Qu         
Sub-Investigator: Xin Qu         
Sub-Investigator: Jin Wan         
Sponsors and Collaborators
Yanjuan Zhu
Investigators
Principal Investigator: Haibo Zhang, MD Guangdong Provincial Hospital of Chinese Medicine, China
  More Information

No publications provided

Responsible Party: Yanjuan Zhu, Department of Oncology, Guangdong Provincial Hospital of Traditional Chinese Medicine
ClinicalTrials.gov Identifier: NCT01929499     History of Changes
Other Study ID Numbers: CIKCC
Study First Received: August 20, 2013
Last Updated: August 27, 2013
Health Authority: China: State Administration of Traditional Chinese Medicine of the People's Republic of China

Keywords provided by Guangdong Provincial Hospital of Traditional Chinese Medicine:
Colon cancer
Cytokine-induced killer cells
Adjuvant immunotherapy
Adjuvant chemotherapy

Additional relevant MeSH terms:
Colonic Neoplasms
Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases

ClinicalTrials.gov processed this record on August 28, 2014