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

November 3, 2014 updated by: Xiao-Jun Wu, Sun Yat-sen University

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

550

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guagzhou, Guangdong, China, 510060
        • Recruiting
        • Sun Yat-sen University Cancer Center
        • Contact:
        • Contact:
        • Principal Investigator:
          • Xiao-Jun Wu, Prof.
        • Sub-Investigator:
          • Rong-Xin Zhang, Doc.
        • Sub-Investigator:
          • Zhi-Zhong Pan, Prof.
        • Sub-Investigator:
          • Xiao-Shi Zhang, Prof.
        • Sub-Investigator:
          • Jian-Chuan Xia, Prof.
        • Sub-Investigator:
          • Dan-Dan Li, Doc.
        • Sub-Investigator:
          • Gong Chen, Prof.
        • Sub-Investigator:
          • Zhen-Hai Lu, Prof.
        • Sub-Investigator:
          • Yu-Jing Fang, Prof.
        • Sub-Investigator:
          • Li-Heng Kong, Doc.
        • Sub-Investigator:
          • Jun-Zhong Lin, Doc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Disease free survival
Time Frame: 3 years
3 years

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sun Yat-sen University

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2014

Primary Completion (Anticipated)

October 1, 2019

Study Registration Dates

First Submitted

October 29, 2014

First Submitted That Met QC Criteria

October 29, 2014

First Posted (Estimate)

October 31, 2014

Study Record Updates

Last Update Posted (Estimate)

November 5, 2014

Last Update Submitted That Met QC Criteria

November 3, 2014

Last Verified

November 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5010010

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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