Colorectal Cancer Clinical Trial
Official title:
Clinical Efficacy of Chemotherapy Combined With Cytokine-induced Killer in Treatment of Patients With Colon Cancer
Verified date | March 2017 |
Source | China Meitan General Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 46 |
Est. completion date | September 15, 2014 |
Est. primary completion date | September 15, 2014 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 78 Years |
Eligibility |
Inclusion Criteria: 1. Tumor, Nodes, Metastasis (TNM) stage of II or III; 2. Patients received radical resection of colon cancer; 3. Pathological diagnosis of adenocarcinoma; 4. Patients not received radiotherapy and chemotherapy before surgery; 5. The preoperative examination confirmed without systemic metastasis; 6. Patient has the Karnofsky score more than 70 points; 7. Subjects signed informed consent. Exclusion Criteria: 1. Patients who was serious allergy to any of the ingredients of drugs used in this study; 2. Patients who unable to comply with the treatment plan or research program; 3. Patients with severe systemic disease that the researchers judged will be unable to complete the study; 4. Patients have severe heart disease, such as myocardial infarction within 6 months; 5. Patients who have received chemotherapy or systemic antitumor therapy (such as monoclonal antibody therapy); 6. Patients received radiotherapy; 7. 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; 8. 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). 9. Patients who do not get effective treatment of inflammation, eye infections or predisposing factors; 10. Physical examination or laboratory findings evidence reasonable doubt who is ill or use of related drugs could affect the study; 11. Patients with serious active infections; 12. Woman who are pregnant or lactating. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
China Meitan General Hospital |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Relapse Free Survival in 2 years | 2 years (24 months) | ||
Secondary | Relapse Free Survival in 3 years | Follow-up: 3 years | ||
Secondary | 5 year Overall Survival | Follow-up: 5 years |
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