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Trial record 45 of 580 for:    Advanced | cancer | bevacizumab

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

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ClinicalTrials.gov Identifier: NCT02487992
Recruitment Status : Active, not recruiting
First Posted : July 2, 2015
Last Update Posted : February 24, 2016
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Colorectal Neoplasms Biological: Cytokine-Induced Killer Cells Phase 2

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Randomized, Controlled, Multicenter Clinical Trial of CIK Plus S-1 and Bevacizumab as Maintenance Treatment for Patients With Advanced Colorectal Cancer
Study Start Date : July 2015
Estimated Primary Completion Date : July 2043
Estimated Study Completion Date : July 2045

Resource links provided by the National Library of Medicine

Drug Information available for: Bevacizumab

Arm Intervention/treatment
Experimental: CIK plus S-1 and Bevacizumab

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.

Biological: Cytokine-Induced Killer Cells
CIK cells transfected with cytokine genes possess an improved proliferation rate and a higher cytotoxic activity as compared to regular CIK cells.

No Intervention: S-1 and Bevacizumab

S-1 is an oral anticancer agent, is a derivative of fluorouracil. Bevacizumab (Avastin) is a recombinant human monoclonal IgG1 antibody, which plays a role in the biological activity of human vascular endothelial growth factor. Bevacizumab is mainly used in the treatment of advanced colorectal cancer.

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.




Primary Outcome Measures :
  1. Overall Survival(OS) [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. Disease-free survival [ Time Frame: 3 months ]

Other Outcome Measures:
  1. Adverse events [ Time Frame: 1 months ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Responsible Party: The First People's Hospital of Changzhou
ClinicalTrials.gov Identifier: NCT02487992     History of Changes
Other Study ID Numbers: CZYY-CRC-001
First Posted: July 2, 2015    Key Record Dates
Last Update Posted: February 24, 2016
Last Verified: February 2016

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Bevacizumab
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents