Chemotherapy Combined With CIK Treating Colon Cancer
Clinical Efficacy of Chemotherapy Combined With Cytokine-induced Killer in Treatment of Patients With Colon Cancer
1 other identifier
interventional
46
0 countries
N/A
Brief Summary
Cytokine-induced killer cells (CIK) is an auxiliary antitumor treatment. The investigators aim to evaluate the clinical efficacy of chemotherapy combined with CIK in the treatment of postoperative colorectal cancer patients. And to provide useful reference for the clinical application of CIK in colorectal cancer patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4 colorectal-cancer
Started May 2012
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 6, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 15, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
September 15, 2014
CompletedFirst Submitted
Initial submission to the registry
March 8, 2017
CompletedFirst Posted
Study publicly available on registry
March 21, 2017
CompletedMarch 21, 2017
March 1, 2017
2.4 years
March 8, 2017
March 14, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Relapse Free Survival in 2 years
2 years (24 months)
Secondary Outcomes (2)
Relapse Free Survival in 3 years
Follow-up: 3 years
5 year Overall Survival
Follow-up: 5 years
Study Arms (2)
Cytokine-induced killer cells + FOLFOX4
EXPERIMENTALCytokine-induced killer cells + FOLFOX4 intervention: Day 1: Oxaliplatin 130 mg/m² IV infusion in 500 mL 5% dextrose in water (D5W); Day 2-6: leucovorin 200mg/m² IV infusion in D5W both given over 2 hours at the same time in separate bags; Day 2-6: 5-FU 500 mg/m² IV bolus given continuously over 4-6 hours.The treatment is given for 4-6 cycles, every 3 weeks. Collected cytokine-induced killer cells (CIK) cells were suspended with 100ml saline (containing 5ml 20% human serum albumin) and given continuously over 2 hours/ day for 3 days.
FOLFOX4
EXPERIMENTALFOLFOX4 intervention: Day 1: Oxaliplatin 130 mg/m² IV infusion in 500 mL 5% dextrose in water (D5W); Day 2-6: leucovorin 200mg/m² IV infusion in D5W both given over 2 hours at the same time in separate bags; Day 2-6: 5-FU 500 mg/m² IV bolus given continuously over 4-6 hours. The treatment is given for 4-6 cycles, every 3 weeks.
Interventions
Day 1: Oxaliplatin 130 mg/m² IV infusion in 500 mL D5W. Day 2-6: leucovorin 200mg/m² IV infusion in D5W both given over 2 hours at the same time in separate bags Day 2-6: 5-FU 500 mg/m² IV bolus given continuously over 4-6 hours. The treatment is given for 4-6 cycles, every 3 weeks. Collected CIK cells were suspended with 100ml saline (containing 5ml 20% human serum albumin) and given continuously over 2 hours/ day for 3 days.
Day 1: Oxaliplatin 130 mg/m² IV infusion in 500 mL D5W. Day 2-6: leucovorin 200mg/m² IV infusion in D5W both given over 2 hours at the same time in separate bags Day 2-6: 5-FU 500 mg/m² IV bolus given continuously over 4-6 hours. The treatment is given for 4-6 cycles, every 3 weeks.
Eligibility Criteria
You may qualify if:
- Tumor, Nodes, Metastasis (TNM) stage of II or III;
- Patients received radical resection of colon cancer;
- Pathological diagnosis of adenocarcinoma;
- Patients not received radiotherapy and chemotherapy before surgery;
- The preoperative examination confirmed without systemic metastasis;
- Patient has the Karnofsky score more than 70 points;
- Subjects signed informed consent.
You may not qualify if:
- Patients who was serious allergy to any of the ingredients of drugs used in this study;
- Patients who unable to comply with the treatment plan or research program;
- Patients with severe systemic disease that the researchers judged will be unable to complete the study;
- Patients have severe heart disease, such as myocardial infarction within 6 months;
- Patients who have received chemotherapy or systemic antitumor therapy (such as monoclonal antibody therapy);
- Patients received radiotherapy;
- Having other malignant tumors in the last 5 years, but not including who has been cured through surgery and survived 5 year of disease-free;
- Any unstable systemic diseases (including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, or myocardial infarction, serious arrhythmias, liver, kidney or metabolic diseases within six months).
- Patients who do not get effective treatment of inflammation, eye infections or predisposing factors;
- Physical examination or laboratory findings evidence reasonable doubt who is ill or use of related drugs could affect the study;
- Patients with serious active infections;
- Woman who are pregnant or lactating.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Li-Min Wang, Dr.
Center for Drug Evaluation, China food and Drug Administration
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal investigator
Study Record Dates
First Submitted
March 8, 2017
First Posted
March 21, 2017
Study Start
May 6, 2012
Primary Completion
September 15, 2014
Study Completion
September 15, 2014
Last Updated
March 21, 2017
Record last verified: 2017-03