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

Shenzhen Hornetcorn Biotechnology

Status and phase: Unknown; Phase 2

Conditions: Gastrointestinal Diseases; Gastric Cancer; Neoplasms; Digestive System Neoplasms; Gastrointestinal Neoplasms

Treatments: Biological: Ag-D-CIK; Drug: Chemotherapy

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02215837

HYK-Gastric Cancer

Details and patient eligibility

About

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.

Full 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).

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Chemotherapy

Sham Comparator group

Description:

After accepting chemotherapy according to NCCN guidelines, patients will just regularly follow up.

Treatment:

Drug: Chemotherapy

Ag-D-CIK

Experimental group

Description:

After accepting chemotherapy according to NCCN guidelines,patients will receive 3 cycles of autologous tumor lysate pulsed D-CIK treatment.

Treatment:

Drug: Chemotherapy

Biological: Ag-D-CIK