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
Updated on 8 November 2020

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

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

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

0/250

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note