Colonic Neoplasms
Conditions
Keywords
Colon cancer, Cytokine-induced killer cells, Adjuvant immunotherapy, Adjuvant chemotherapy
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).
Interventions
BIOLOGICALcytokine-induced killer cells
Sponsors
Yanjuan Zhu
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| DFS (Disease free survival) | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. | Patients who were survival at the end of study or lost to follow-up were censored |
| Side effect | 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 | Up to 6 months | During the period of CIK infusion |
| QoL (quality of life) | Up to 1 year | During the period of chemotherapy and CIK infusion |
Countries
China
Contacts
Primary ContactYanjuan Zhu
Backup ContactHaibo Zhang, MD
Outcome results
None listed