Efficacy of Adjuvant Cytokine-induced Killer Cells in Colon Cancer
NCT ID: NCT01929499
Last Updated: 2013-08-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
210 participants
INTERVENTIONAL
2013-09-30
2019-08-31
Brief Summary
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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).
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
cytokine-induced killer cells
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.
cytokine-induced killer cells
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）.
No interventions assigned to this group
Interventions
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cytokine-induced killer cells
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
80 Years
ALL
No
Sponsors
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Yanjuan Zhu
OTHER
Responsible Party
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Yanjuan Zhu
Department of Oncology
Principal Investigators
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Haibo Zhang, MD
Role: PRINCIPAL_INVESTIGATOR
Guangdong Provincial Hospital of Chinese Medicine, China
Locations
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Guangdong Provincial Hospital of Chinese Medicine
Guangzhou, Guangdong, China
Countries
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Central Contacts
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Facility Contacts
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Yanjuan Zhu
Role: primary
Haibo Zhang
Role: backup
Other Identifiers
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CIKCC
Identifier Type: -
Identifier Source: org_study_id