Efficacy of Adjuvant Cytokine-induced Killer Cells in Colon Cancer (CIKCC)
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 Design:||Allocation: Randomized
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|
- 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
- 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
- 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)
- T lymphocyte subset [ Time Frame: Up to 6 months ]During the period of CIK infusion
- QoL (quality of life) [ Time Frame: Up to 1 year ]During the period of chemotherapy and CIK infusion
|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)|
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
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
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）.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01929499
|Contact: Yanjuan Zhu||(+86)firstname.lastname@example.org|
|Contact: Haibo Zhang, MD||(+86)email@example.com|
|Guangdong Provincial Hospital of Chinese Medicine||Not yet recruiting|
|Guangzhou, Guangdong, China, 510120|
|Contact: Yanjuan Zhu (+86)13902260217 firstname.lastname@example.org|
|Contact: Haibo Zhang (+86)13724123615 email@example.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|
|Principal Investigator:||Haibo Zhang, MD||Guangdong Provincial Hospital of Chinese Medicine, China|