Back to resultsEfficacy of Adjuvant Cytokine-induced Killer Cells in Colon Cancer (CIKCC)
Primary Purpose
Colonic Neoplasms
Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
cytokine-induced killer cells
Sponsored by
About this trial
This is an interventional treatment trial for Colonic Neoplasms focused on measuring Colon cancer, Cytokine-induced killer cells, Adjuvant immunotherapy, Adjuvant chemotherapy
Eligibility 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.
Sites / Locations
- Guangdong Provincial Hospital of Chinese Medicine
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
No Intervention
Arm Label
synchronous CIK group
sequence CIK group
control group
Arm Description
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.
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.
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）.
Outcomes
Primary Outcome Measures
DFS (Disease free survival)
Patients who were recurrence free at the end of study or lost to follow-up were censored
Secondary Outcome Measures
OS (overall survival)
Patients who were survival at the end of study or lost to follow-up were censored
Side effect
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
During the period of CIK infusion
QoL (quality of life)
During the period of chemotherapy and CIK infusion
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01929499
Brief Title
Efficacy of Adjuvant Cytokine-induced Killer Cells in Colon Cancer
Acronym
CIKCC
Official Title
Efficacy of Adjuvant Immunotherapy With Cytokine-induced Killer Cells in Patients With Stage II/III Colon Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
August 2013
Overall Recruitment Status
Unknown status
Study Start Date
September 2013 (undefined)
Primary Completion Date
August 2016 (Anticipated)
Study Completion Date
August 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Yanjuan Zhu
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colonic Neoplasms
Keywords
Colon cancer, Cytokine-induced killer cells, Adjuvant immunotherapy, Adjuvant chemotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
210 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
synchronous CIK group
Arm Type
Experimental
Arm Description
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.
Arm Title
sequence CIK group
Arm Type
Experimental
Arm Description
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.
Arm Title
control group
Arm Type
No Intervention
Arm Description
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）.
Intervention Type
Biological
Intervention Name(s)
cytokine-induced killer cells
Other Intervention Name(s)
CIK, cytokine induced killer cells
Primary Outcome Measure Information:
Title
DFS (Disease free survival)
Description
Patients who were recurrence free at the end of study or lost to follow-up were censored
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.
Secondary Outcome Measure Information:
Title
OS (overall survival)
Description
Patients who were survival at the end of study or lost to follow-up were censored
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.
Title
Side effect
Description
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)
Time Frame
Up to 2 years
Title
T lymphocyte subset
Description
During the period of CIK infusion
Time Frame
Up to 6 months
Title
QoL (quality of life)
Description
During the period of chemotherapy and CIK infusion
Time Frame
Up to 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yanjuan Zhu
Phone
(+86)13902260217
Email
zyjsophy@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Haibo Zhang, MD
Phone
(+86)13724123615
Email
haibozh@aliyun.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Haibo Zhang, MD
Organizational Affiliation
Guangdong Provincial Hospital of Chinese Medicine, China
Official's Role
Principal Investigator
Facility Information:
Facility Name
Guangdong Provincial Hospital of Chinese Medicine
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510120
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yanjuan Zhu
Phone
(+86)13902260217
Email
zyjsophy@hotmail.com
First Name & Middle Initial & Last Name & Degree
Haibo Zhang
Phone
(+86)13724123615
Email
haibozh@aliyun.com
First Name & Middle Initial & Last Name & Degree
Haibo Zhang, MD
First Name & Middle Initial & Last Name & Degree
Yanjuan Zhu
First Name & Middle Initial & Last Name & Degree
Yong Li
First Name & Middle Initial & Last Name & Degree
Jianping Bai
First Name & Middle Initial & Last Name & Degree
Lirong Liu
First Name & Middle Initial & Last Name & Degree
Yihong Liu
First Name & Middle Initial & Last Name & Degree
Yanchun Qu
First Name & Middle Initial & Last Name & Degree
Xin Qu
First Name & Middle Initial & Last Name & Degree
Jin Wan
12. IPD Sharing Statement
Learn more about this trial
Efficacy of Adjuvant Cytokine-induced Killer Cells in Colon Cancer
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