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

Colorectal Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02487992
• Other study ID #: CZYY-CRC-001
• Status: Active, not recruiting
• Phase: Phase 2
• First received: June 30, 2015
• Last updated: February 23, 2016
• Start date: July 2015
• Est. completion date: July 2045

Study information

• Verified date: February 2016
• Source: The First People's Hospital of Changzhou
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Health and Family Planning Commission of Changzhou
• Study type: Interventional

Clinical Trial 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.

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) .

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1200
• Est. completion date: July 2045
• Est. primary completion date: July 2043
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Patients who can accept curative operations 18-70 years old

• Histologically confirmed with colorectal cancer at stage ?

• 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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colorectal Neoplasms

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
The First People's Hospital of Changzhou

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Adverse events		1 months	Yes
Primary	Overall Survival(OS)		3 months	No
Secondary	Disease-free survival		3 months	No