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

Shenzhen Hornetcorn Bio-technology Company, LTD40 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Gastric Cancer Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Gastrointestinal Diseases

Interventions

ChemotherapyDRUG

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.

Ag-D-CIKBIOLOGICAL

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Locations (2)

Affiliated Tumor Hospital of Guangzhou Medical University Immunotherapy center

Guangzhou, Guangdong, China

Jingzhou Central Hospital Immunotherapy center

Jingzhou, Hubei, China

Outcomes

Primary Outcomes

Progress-free survival

Time frame: 3 years

Secondary Outcomes

Overall survival

Time frame: 3 years

Quality of life (QOL)

Time frame: 3 years

Phenotypic analysis of T cells

The number of CD3+ (or CD8+ or CD4+ or CD56+) T cell

Time frame: 1 years

Severity of adverse events

According to National Cancer Institute Common Terminology Criteria for Adverse Events（NCI-CTCAE)

Time frame: 1 years

Data from ClinicalTrials.gov

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