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

Sponsor
Sun Yat-sen University (Other)
Overall Status
Unknown status
CT.gov ID
NCT02280278
Collaborator
(none)
550
Enrollment
1
Location
2
Arms

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Radical surgery
  • Drug: Adjuvant chemotherapy
  • Biological: Cytokine-induced killer cell immunotherapy
 Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
550 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
The Effectiveness and Safety of Adjuvant Cytokine-induced Killer Cell Immunotherapy for Stage III Colorectal Cancer Patients After Chemotherapy
Study Start Date :
Oct 1, 2014
Anticipated Primary Completion Date :
Oct 1, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: CIK group

Stage III Colon Cancer patients after radical operation and adjuvant chemotherapy will receive 8 cycles of CIK therapy in this group.

Procedure: Radical surgery

Drug: Adjuvant chemotherapy

Biological: Cytokine-induced killer cell immunotherapy
Active Comparator: Control group

Stage III Colon Cancer patients will only receive radical operation and adjuvant chemotherapy.

Procedure: Radical surgery

Drug: Adjuvant chemotherapy

Outcome Measures

Primary Outcome Measures

  1. Disease free survival [3 years]

Secondary Outcome Measures

  1. survival rate [5 years]

  2. toxin-side effect [1 year]

    Toxin-side effect will be assessed by laboratory test, clinicians and questionary

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Sun Yat-Sen University Cancer Center Guagzhou Guangdong China 510060

Sponsors and Collaborators

  • Sun Yat-sen University

Investigators

  • Principal Investigator: Xiao-Jun Wu, Prof., Sun Yat-sen University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Xiao-Jun Wu, Professor, Sun Yat-sen University
ClinicalTrials.gov Identifier:
NCT02280278
Other Study ID Numbers:
  • 5010010
First Posted:
Oct 31, 2014
Last Update Posted:
Nov 5, 2014
Last Verified:
Nov 1, 2014
Keywords provided by Xiao-Jun Wu, Professor, Sun Yat-sen University
colon cancer
cytokine-induced killer cell immunotherapy
Additional relevant MeSH terms:
Colonic Neoplasms

Study Results

No Results Posted as of Nov 5, 2014