The Study of CIK Plus S-1 and Bevacizumab as Maintenance Treatment for Patients With Advanced Colorectal Cancer

Phase 2

Active, not recruiting

• Conditions: Colorectal Neoplasms
• Interventions: Biological: Cytokine-Induced Killer Cells

• Registration Number: NCT02487992
• Lead Sponsor: The First People's Hospital of Changzhou

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of cytokine-induced killer cell (CIK) plus S-1 and Bevacizumab vs S-1 and Bevacizumab as Maintenance Treatment for patients with advanced colorectal cancer.

Detailed Description

1200 patients with stage Ⅳ colorectal cancer,who had received surgery and chemotherapy,will be randomly divided into group A（receive CIK plus S-1 and Bevacizumab ) or group B（just receive S-1 and Bevacizumab),and the randomize ratio will be 1:1. Patients in group A will receive 3 cycles of CIK treatment (every 1 year) and Apatinib (continuous).Patients in group B will receive only S-1 and Bevacizumab (continuous) .

Study Timeline

• Study First Submitted: 2015-06-30
• Study First Submitted QC: 2015-06-30
• Study Start: 2015-07
• Study First Posted: 2015-07-02
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-23
• Last Update Posted: 2016-02-24
• Primary Completion: 2043-07
• Study Completion: 2045-07

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 1200

Inclusion Criteria

• Patients who can accept curative operations 18-70 years old
• Histologically confirmed with colorectal cancer at stage Ⅳ
• Patients who can accept oral drugs;
• Eastern Cooperative Oncology Group (ECOG) performance status was 0 - 1.

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Exclusion Criteria

• Hemoglobin<8.0 g/dL,White blood cell <3 X 10^9/L;Platelet count <75 X 10^9/L; alanine aminotransferase, glutamic-oxalacetic transaminase, blood urine nitrogen and creatinine more than normal limits on 3.0 times
• Known or suspected allergy to the investigational agent or any agent given in association with this trial
• Pregnant or lactating patients
• Known history of Human Immunodeficiency Virus (HIV), Hepatitis C Virus (HCV) or TreponemaPallidun (TP) infection
• Patients who are suffering from serious autoimmune disease
• Patients who had used long time or are using immunosuppressant
• Patients who had active infection
• Patients who are suffering from serious organ dysfunction
• Patients who are suffering from other cancer
• Other situations that the researchers considered unsuitable for this study.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CIK plus S-1 and Bevacizumab	Cytokine-Induced Killer Cells	Cytokine-Induced Killer Cells are used to treat advanced colorectal cancer patients with S-1 and Bevacizumab. S-1, 60mg,p.o.,Bid,d2-15. Bevacizumab (Avastin),7.5mg/kg,ivgtt,d1. 3 weeks is a cycle. Continue until the disease progress. Cytokine-induced killer cells 3 cycles,every 1 year. Continue until the disease progress.

Primary Outcome Measures

Name	Time	Method
Overall Survival(OS)	3 months

Secondary Outcome Measures

Name	Time	Method
Disease-free survival	3 months