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NCT Number: NCT02487992

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

About this study

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) .

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

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.

Treatment and study plan

Cytokine-Induced Killer Cells

Biological

CIK cells transfected with cytokine genes possess an improved proliferation rate and a higher cytotoxic activity as compared to regular CIK cells.

Primary outcomes

  1. Overall Survival(OS)

    Time frame: 3 months

Secondary outcomes

  1. Disease-free survival

    Time frame: 3 months

Other outcomes

  1. Adverse events

    Time frame: 1 months

Sponsors and collaborators

Lead sponsor

The First People's Hospital of Changzhou

Other

Registry information

Official study title

The Randomized, Controlled, Multicenter Clinical Trial of CIK Plus S-1 and Bevacizumab as Maintenance Treatment for Patients With Advanced Colorectal Cancer

Important dates

Study start
2015
Primary completion
2043
Study completion
2045
First posted
Jul 2, 2015
Registry last updated
Feb 24, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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