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

Stage III Colon Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02280278
• Other study ID #: 5010010
• Status: Recruiting
• Phase: Phase 3
• First received: October 29, 2014
• Last updated: November 3, 2014
• Start date: October 2014

Study information

• Verified date: November 2014
• Source: Sun Yat-sen University
• Contact: Xiao-Jun Wu, Prof.
• Phone: +86 20 87343456
• Email: wuxj[@]sysucc.org.cn
• Is FDA regulated: No
• Health authority: PR China: Sun Yat-Sen University Cancer Center
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 550
• Est. primary completion date: October 2019
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colorectal Neoplasms
• Stage III Colon Cancer

Intervention

Procedure:
• Radical surgery

Drug:
• Adjuvant chemotherapy

Biological:
• Cytokine-induced killer cell immunotherapy

Locations

Country	Name	City	State
China	Sun Yat-Sen University Cancer Center	Guagzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease free survival		3 years	No
Secondary	survival rate		5 years	No
Secondary	toxin-side effect	Toxin-side effect will be assessed by laboratory test, clinicians and questionary	1 year	Yes