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

  • STATUS
    Recruiting
  • participants needed
    550
  • sponsor
    Sun Yat-sen University
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Updated on 8 November 2020
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Summary

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.

Details
Condition Stage III Colon Cancer
Treatment Adjuvant chemotherapy, Radical Surgery, Cytokine-induced killer cell immunotherapy
Clinical Study IdentifierNCT02280278
SponsorSun Yat-sen University
Last Modified on8 November 2020

Eligibility

 Yes No Not Sure

Inclusion Criteria

Is your age between 18 yrs and 70 yrs?
Gender: Male or Female
Do you have Stage III Colon Cancer?
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
Clear my responses
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