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

August 27, 2013 updated by: Yanjuan Zhu

Efficacy of Adjuvant Immunotherapy With Cytokine-induced Killer Cells in Patients With Stage II/III Colon Cancer

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).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

210

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510120
        • Guangdong Provincial Hospital of Chinese Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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）.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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.
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)
Up to 2 years
T lymphocyte subset
Time Frame: Up to 6 months
During the period of CIK infusion
Up to 6 months
QoL (quality of life)
Time Frame: Up to 1 year
During the period of chemotherapy and CIK infusion
Up to 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yanjuan Zhu

Investigators

  • Principal Investigator: Haibo Zhang, MD, Guangdong Provincial Hospital of Chinese Medicine, China

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2013

Primary Completion (Anticipated)

August 1, 2016

Study Completion (Anticipated)

August 1, 2019

Study Registration Dates

First Submitted

August 20, 2013

First Submitted That Met QC Criteria

August 21, 2013

First Posted (Estimate)

August 28, 2013

Study Record Updates

Last Update Posted (Estimate)

August 29, 2013

Last Update Submitted That Met QC Criteria

August 27, 2013

Last Verified

August 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CIKCC

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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