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

NCT ID: NCT02215837

Last Updated: 2016-05-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-08-31
• Study Completion Date: 2018-05-31

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).

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Chemotherapy

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

Group Type: SHAM_COMPARATOR

Chemotherapy

Intervention Type: DRUG

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-CIK

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

Group Type: EXPERIMENTAL

Chemotherapy

Intervention Type: DRUG

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-CIK

Intervention Type: BIOLOGICAL

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.

Interventions

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.

Intervention Type: DRUG

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.

Intervention Type: BIOLOGICAL

Other Intervention Names

FOLFOX

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Affiliated Cancer Hospital & Institute of Guangzhou Medical University

OTHER

Sponsor Role: collaborator

Jingzhou Central Hospital

OTHER

Sponsor Role: collaborator

Shenzhen Hornetcorn Bio-technology Company, LTD

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hai Y Liu, Professor

Role: PRINCIPAL_INVESTIGATOR

Affiliated Tumor Hospital of Guangzhou Medical University immunotherapy center

Locations

Affiliated Tumor Hospital of Guangzhou Medical University Immunotherapy center

Guangzhou, Guangdong, China

Jingzhou Central Hospital Immunotherapy center

Jingzhou, Hubei, China

Countries

China

Other Identifiers

HYK-Gastric Cancer

Identifier Type: -

Identifier Source: org_study_id