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

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

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02215837

Enrollment

Registered

2014-08-13

Start date

2014-08-31

Completion date

2018-05-31

Last updated

2016-05-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Digestive System Neoplasms, Gastric Cancer, Gastrointestinal Diseases, Gastrointestinal Neoplasms, Neoplasms

Keywords

Gastric cancer, D-CIK, Autologous tumor lysate

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).

Interventions

DRUGChemotherapy

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.

BIOLOGICALAg-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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

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.

Design outcomes

Primary

Measure	Time frame
Progress-free survival	3 years

Secondary

Measure	Time frame	Description
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)

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026