Efficacy of Adjuvant Cytokine-induced Killer Cells in Colon Cancer
CIKCC
Efficacy of Adjuvant Immunotherapy With Cytokine-induced Killer Cells in Patients With Stage II/III Colon Cancer
1 other identifier
interventional
210
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Sep 2013
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 20, 2013
CompletedFirst Posted
Study publicly available on registry
August 28, 2013
CompletedStudy Start
First participant enrolled
September 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2019
CompletedAugust 29, 2013
August 1, 2013
2.9 years
August 20, 2013
August 27, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
DFS (Disease free survival)
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 Outcomes (4)
OS (overall survival)
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
Up to 2 years
T lymphocyte subset
Up to 6 months
QoL (quality of life)
Up to 1 year
Study Arms (3)
synchronous CIK group
EXPERIMENTALAfter 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.
sequence CIK group
EXPERIMENTALAfter 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.
control group
NO INTERVENTIONAfter 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）.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Yanjuan Zhulead
Study Sites (1)
Guangdong Provincial Hospital of Chinese Medicine
Guangzhou, Guangdong, 510120, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Haibo Zhang, MD
Guangdong Provincial Hospital of Chinese Medicine, China
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Department of Oncology
Study Record Dates
First Submitted
August 20, 2013
First Posted
August 28, 2013
Study Start
September 1, 2013
Primary Completion
August 1, 2016
Study Completion
August 1, 2019
Last Updated
August 29, 2013
Record last verified: 2013-08