Chemotherapy Combined With CIK Treating Colon Cancer

Clinical Efficacy of Chemotherapy Combined With Cytokine-induced Killer in Treatment of Patients With Colon Cancer

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.

Study Overview

• Status: Completed
• Conditions: Postoperative Complications; Colorectal Cancer; Survival; Cytokine-induced Killer Cells
• Intervention / Treatment: Drug: Cytokine-induced killer cells+ FOLFOX4; Drug: FOLFOX4

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.

• Study Type: Interventional
• Enrollment (Actual): 46
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 78 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: 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.; Other Names: CIK + Oxaliplatin + leucovorin + 5-FU
Experimental: 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.	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.; Other Names: Oxaliplatin + leucovorin + 5-FU

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Relapse Free Survival in 2 years	2 years (24 months)

Secondary Outcome Measures

Outcome Measure	Time Frame
Relapse Free Survival in 3 years	Follow-up: 3 years
5 year Overall Survival	Follow-up: 5 years

Collaborators and Investigators

• Sponsor: China Meitan General Hospital
• Investigators: Principal Investigator: Li-Min Wang, Dr., Center for Drug Evaluation, China food and Drug Administration

Study record dates

Study Major Dates

• Study Start (Actual): May 6, 2012
• Primary Completion (Actual): September 15, 2014
• Study Completion (Actual): September 15, 2014

Study Registration Dates

• First Submitted: March 8, 2017
• First Submitted That Met QC Criteria: March 14, 2017
• First Posted (Actual): March 21, 2017

Study Record Updates

• Last Update Posted (Actual): March 21, 2017
• Last Update Submitted That Met QC Criteria: March 14, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Protective Agents; Micronutrients; Vitamins; Antidotes; Vitamin B Complex; Fluorouracil; Oxaliplatin; Leucovorin; Levoleucovorin
• Other Study ID Numbers: CIK-2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: whether individual participant data (IPD) could be shared must obtain the consent of the subjects

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No