Chemotherapy Combined With CIK Treating Colon Cancer

NCT ID: NCT03084809

Last Updated: 2017-03-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-05-06
• Study Completion Date: 2014-09-15

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.

Detailed Description

Over the past decade, advances in combination chemotherapy regimens for colorectal cancer have led to significant improvement in progression-free and overall survival. Cytokine-induced killer cells (CIK) is an auxiliary antitumor treatment. Research has demonstrated the median overall survival (OS) in patients received CIK combined with chemotherapy (5-Fluorouridine, leucovorin and oxaliplatin [FOLFOX4] plan) was significantly increased compared with that in patients received chemotherapy alone. Furthermore, there was a trend toward superior progression-free survival time (PFS) in patients received CIK combined with chemotherapy compared with that in patients received chemotherapy alone. The investigators aim to evaluate the clinical efficacy of chemotherapy (FOLFOX4) 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.

Conditions

Colorectal Cancer; Cytokine-induced Killer Cells; Postoperative Complications; Survival

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cytokine-induced killer cells + FOLFOX4

Cytokine-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.

Group Type: EXPERIMENTAL

Cytokine-induced killer cells+ FOLFOX4

Intervention Type: DRUG

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.

FOLFOX4

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.

Group Type: EXPERIMENTAL

FOLFOX4

Intervention Type: DRUG

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.

Interventions

Cytokine-induced killer cells+ FOLFOX4

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.

Intervention Type: DRUG

FOLFOX4

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.

Intervention Type: DRUG

Other Intervention Names

CIK + Oxaliplatin + leucovorin + 5-FU; Oxaliplatin + leucovorin + 5-FU

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 78 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

China Meitan General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Hao Peng

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Li-Min Wang, Dr.

Role: PRINCIPAL_INVESTIGATOR

Center for Drug Evaluation, China food and Drug Administration

Other Identifiers

CIK-2

Identifier Type: -

Identifier Source: org_study_id