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

Phase 2

• Conditions: Neoplasms; Digestive System Neoplasms; Gastric Cancer; Gastrointestinal Neoplasms; Gastrointestinal Diseases
• Interventions: Drug: Chemotherapy; Biological: Ag-D-CIK

• Registration Number: NCT02215837
• Lead Sponsor: Shenzhen Hornetcorn Bio-technology Company, LTD

Brief 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.

Detailed 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).

Study Timeline

• Study Start: 2014-08
• Study First Submitted: 2014-08-12
• Study First Submitted QC: 2014-08-12
• Study First Posted: 2014-08-13
• Status Verified: 2015-11
• Last Update Submitted: 2016-05-23
• Last Update Posted: 2016-05-24
• Primary Completion: 2018-05
• Study Completion: 2018-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Patients who can accept curative operations
• 18~80 years old
• Histologically confirmed with gastric cancer at stage Ⅰ~Ⅲ
• 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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ag-D-CIK	Chemotherapy	After accepting chemotherapy according to NCCN guidelines,patients will receive 3 cycles of autologous tumor lysate pulsed D-CIK treatment.
Ag-D-CIK	Ag-D-CIK	After accepting chemotherapy according to NCCN guidelines,patients will receive 3 cycles of autologous tumor lysate pulsed D-CIK treatment.
Chemotherapy	Chemotherapy	After accepting chemotherapy according to NCCN guidelines, patients will just regularly follow up.

Primary Outcome Measures

Name	Time	Method
Progress-free survival	3 years

Secondary Outcome Measures

Name	Time	Method
Overall survival	3 years
Quality of life (QOL)	3 years
Phenotypic analysis of T cells	1 years	The number of CD3+ (or CD8+ or CD4+ or CD56+) T cell
Severity of adverse events	1 years	According to National Cancer Institute Common Terminology Criteria for Adverse Events（NCI-CTCAE)

Trial Locations

Locations (2)

Jingzhou Central Hospital Immunotherapy center; 🇨🇳 Jingzhou, Hubei, China

Affiliated Tumor Hospital of Guangzhou Medical University Immunotherapy center; 🇨🇳 Guangzhou, Guangdong, China