Study of Autologous Tumor Lysate-pulsed D-CIK Combined With Chemotherapy for Gastric Cancer

Gastric Cancer Clinical Trial

Official title:

Randomized,Controlled,Multicenter Study of Autologous Tumor Lysate-pulsed Dendritic and Cytokine-induced Killer Cells(Ag-D-CIK) Combined With Chemotherapy for Gastric Cancer.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02215837
• Other study ID #: HYK-Gastric Cancer
• Status: Active, not recruiting
• Phase: Phase 2
• First received: August 12, 2014
• Last updated: May 23, 2016
• Start date: August 2014
• Est. completion date: May 2018

Study information

• Verified date: November 2015
• Source: Shenzhen Hornetcorn Bio-technology Company, LTD
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the safety and efficacy of chemotherapy combined with autologous tumor Lysate-pulsed dendritic with cytokine-induced killer cell (Ag-D-CIK) for gastric cancer.

Description:

40 patients with stage Ⅰ～Ⅲ Gastric Cancer,who had received surgery and kept their tumor tissue,will be randomly divided into group A（receive Ag-D-CIK treatment and chemotherapy) or group B（just receive chemotherapy),and the randomize ratio will be 1:1. Patients in group A will receive 3 cycles of Ag-D-CIK treatment (every 1 months) and 4 cycles of chemotherapy (every 2 weeks).Patients in group B will receive only 4 cycles chemotherapy（every 2 weeks).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: May 2018
• Est. primary completion date: May 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Patients who can accept curative operations

• 18~80 years old

• Histologically confirmed with gastric cancer at stage ?~?

• Patients who can accept radical gastrectomy;

• 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; ALT, AST, BUN and Cr 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, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Digestive System Diseases
• Digestive System Neoplasms
• Gastric Cancer
• Gastrointestinal Diseases
• Gastrointestinal Neoplasms
• Neoplasms
• Stomach Neoplasms

Intervention

Drug:
• Chemotherapy
Oxaliplatin 85mg/m2 IV over 2 hours, day 1; Leucovorin 400mg/m2 IV over 2 hours, day 1; 5-FU 400mg/m2 IV bolus on day 1, then 1200mg/m2/day for 2 days IV continuous infusion; Repeat every 2 weeks.

Biological:
• Ag-D-CIK
8×10^9 autologous tumor lysate pulsed D-CIK cells for each infusion, IV (in the vein) for 3 cycles, each cycle received four infusions on day 14, 16, 30 and 32.

Locations

Country	Name	City	State
China	Affiliated Tumor Hospital of Guangzhou Medical University Immunotherapy center	Guangzhou	Guangdong
China	Jingzhou Central Hospital Immunotherapy center	Jingzhou	Hubei

Sponsors (3)

Lead Sponsor	Collaborator
Shenzhen Hornetcorn Bio-technology Company, LTD	Affiliated Tumor Hospital of Guangzhou Medical University, Jingzhou Central Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progress-free survival		3 years	No
Secondary	Overall survival		3 years	No
Secondary	Quality of life (QOL)		3 years	No
Secondary	Phenotypic analysis of T cells	The number of CD3+ (or CD8+ or CD4+ or CD56+) T cell	1 years	No
Secondary	Severity of adverse events	According to National Cancer Institute Common Terminology Criteria for Adverse Events(NCI-CTCAE)	1 years	Yes