Cytokine-induced Killer Cell Immunotherapy for Surgical Resected Stage III Colorectal Cancer Patients After Chemotherapy

Study Overview
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Brief Summary
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We hypothesize through this randomized, prospective, single center adjuvant study, that cytokine-induced killer cell in patients with stage III colon cancer can improve survival in this patient population over control. Stage III colon cancer patients can benefit most from adjuvant chemotherapy, but the 5 year survival rate is still around 60%. We wish CIK cell therapy can improve the survival rate of stage III colon cancer patients.

Official Title
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The Effectiveness and Safety of Adjuvant Cytokine-induced Killer Cell Immunotherapy for Stage III Colorectal Cancer Patients After Chemotherapy

Conditions
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Stage III Colon Cancer

Intervention / Treatment
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* Procedure: Radical surgery
* Drug: Adjuvant chemotherapy
* Biological: Cytokine-induced killer cell immunotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female outpatient of ≥ 18 years of age or ≥ country's legal age for adult consent Stage III colon cancer undergone complete resection of primary tumor Completed standard adjuvant chemotherapy within 120 days of completion of standard therapy ECOG performancer status 0-2 Satisfactory haematological or biochemical functions (tests should be carried out within 8 weeks prior to randomisation): Results of clinical investigations carried out within 8 weeks prior to randomisation can be used in place of the required screening investigations. Patients with mild laboratory abnormalities can be included at the discretion by the site principal investigator, and after approval by ASCOLT Trial Management Group ANC ≥ 1.0 x 109/L Platelets ≥ 100 x 109/L Creatinine clearance ≥ 30 mL/min Total bilirubin ≤ 2.0 x the upper limit normal AST & ALT ≤ 5 x the upper limit normal Completed the following investigations Completed the following investigations Exclusion Criteria: HIV positive or other Immunodeficiency disease recently use of high dose glucocorticoid Uncontrolled hypertension (untreated systolic blood pressure > 160 mmHg, or diastolic blood pressure > 95 mmHg) History of recent cancers (except for colorectal cancers, non-melanoma skin cancers, basal cell carcinomas, squamous cell carcinomas) in the past 5 years Patient having known allergy to capecitabine or Oxaliplatin Pregnant, lactating

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CIK group<br>Stage III Colon Cancer patients after radical operation and adjuvant chemotherapy will receive 8 cycles of CIK therapy in this group. | Procedure: Radical surgery<br> <br> Drug: Adjuvant chemotherapy<br> <br> Biological: Cytokine-induced killer cell immunotherapy<br> <br> |
| Active Comparator: Control group<br>Stage III Colon Cancer patients will only receive radical operation and adjuvant chemotherapy. | Procedure: Radical surgery<br> <br> Drug: Adjuvant chemotherapy<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease free survival |  | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| survival rate |  | 5 years | 
| toxin-side effect | Toxin-side effect will be assessed by laboratory test, clinicians and questionary | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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colon cancer, cytokine-induced killer cell immunotherapy