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Chemotherapy Combined With CIK Treating Colon Cancer

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ClinicalTrials.gov Identifier: NCT03084809
Recruitment Status : Completed
First Posted : March 21, 2017
Last Update Posted : March 21, 2017
Sponsor:
Information provided by (Responsible Party):
Hao Peng, China Meitan General Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Cytokine-induced Killer Cells Postoperative Complications Survival Drug: Cytokine-induced killer cells+ FOLFOX4 Drug: FOLFOX4 Phase 4

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 46 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Group 1: chemotherapy (5-Fluorouridine, leucovorin and oxaliplatin [FOLFOX4]) combined with cytokine-induced killer cells (CIK) Group 2: chemotherapy (5-Fluorouridine, leucovorin and oxaliplatin [FOLFOX4])
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Efficacy of Chemotherapy Combined With Cytokine-induced Killer in Treatment of Patients With Colon Cancer
Actual Study Start Date : May 6, 2012
Actual Primary Completion Date : September 15, 2014
Actual Study Completion Date : September 15, 2014

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Arms and Interventions
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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 Name: 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 Name: Oxaliplatin + leucovorin + 5-FU


Outcome Measures
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Primary Outcome Measures :
  1. Relapse Free Survival in 2 years [ Time Frame: 2 years (24 months) ]

Secondary Outcome Measures :
  1. Relapse Free Survival in 3 years [ Time Frame: Follow-up: 3 years ]
  2. 5 year Overall Survival [ Time Frame: Follow-up: 5 years ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 78 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03084809


Sponsors and Collaborators
China Meitan General Hospital
Investigators
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Principal Investigator: Li-Min Wang, Dr. Center for Drug Evaluation, China food and Drug Administration
More Information
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Responsible Party: Hao Peng, Principal investigator, China Meitan General Hospital
ClinicalTrials.gov Identifier: NCT03084809     History of Changes
Other Study ID Numbers: CIK-2
First Posted: March 21, 2017    Key Record Dates
Last Update Posted: March 21, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: whether individual participant data (IPD) could be shared must obtain the consent of the subjects

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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
Additional relevant MeSH terms:
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Postoperative Complications
Pathologic Processes
Leucovorin
Oxaliplatin
Fluorouracil
Antineoplastic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Immunosuppressive Agents
 Immunologic Factors
Physiological Effects of Drugs
Antidotes
Protective Agents
Vitamin B Complex
Vitamins
Micronutrients
Nutrients
Growth Substances