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

Phase 3

• Conditions: Stage III Colon Cancer
• Interventions: Procedure: Radical surgery; Drug: Adjuvant chemotherapy; Biological: Cytokine-induced killer cell immunotherapy

• Registration Number: NCT02280278
• Lead Sponsor: Sun Yat-sen University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-10
• Study First Submitted: 2014-10-29
• Study First Submitted QC: 2014-10-29
• Study First Posted: 2014-10-31
• Status Verified: 2014-11
• Last Update Submitted: 2014-11-03
• Last Update Posted: 2014-11-05
• Primary Completion: 2019-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 550

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CIK group	Radical surgery	Stage III Colon Cancer patients after radical operation and adjuvant chemotherapy will receive 8 cycles of CIK therapy in this group.
CIK group	Adjuvant chemotherapy	Stage III Colon Cancer patients after radical operation and adjuvant chemotherapy will receive 8 cycles of CIK therapy in this group.
CIK group	Cytokine-induced killer cell immunotherapy	Stage III Colon Cancer patients after radical operation and adjuvant chemotherapy will receive 8 cycles of CIK therapy in this group.
Control group	Radical surgery	Stage III Colon Cancer patients will only receive radical operation and adjuvant chemotherapy.
Control group	Adjuvant chemotherapy	Stage III Colon Cancer patients will only receive radical operation and adjuvant chemotherapy.

Primary Outcome Measures

Name	Time	Method
Disease free survival	3 years

Secondary Outcome Measures

Name	Time	Method
survival rate	5 years
toxin-side effect	1 year	Toxin-side effect will be assessed by laboratory test, clinicians and questionary

Trial Locations

Locations (1)

Sun Yat-Sen University Cancer Center; 🇨🇳 Guagzhou, Guangdong, China