Overview

This trial is active, not recruiting.

Condition colorectal neoplasms
Treatment cytokine-induced killer cells
Phase phase 2
Sponsor The First People's Hospital of Changzhou
Start date July 2015
End date July 2043
Trial size 1200 participants
Trial identifier NCT02487992, CZYY-CRC-001

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
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.
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 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 Outcomes

Measure
Overall Survival(OS)
time frame: 3 months

Secondary Outcomes

Measure
Disease-free survival
time frame: 3 months

Eligibility Criteria

Male or female participants from 18 years up to 75 years old.

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.

Additional Information

Official title The Randomized, Controlled, Multicenter Clinical Trial of CIK Plus 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) .
Trial information was received from ClinicalTrials.gov and was last updated in February 2016.
Information provided to ClinicalTrials.gov by The First People's Hospital of Changzhou.