Back to resultsStudy of Autologous Tumor Lysate-pulsed D-CIK Combined With Chemotherapy for Gastric Cancer
Primary Purpose
Gastric Cancer, Neoplasms, Gastrointestinal Neoplasms
Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Chemotherapy
Ag-D-CIK
Sponsored by
About this trial
This is an interventional treatment trial for Gastric Cancer focused on measuring Gastric cancer, D-CIK, Autologous tumor lysate
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.
Sites / Locations
- Affiliated Tumor Hospital of Guangzhou Medical University Immunotherapy center
- Jingzhou Central Hospital Immunotherapy center
Arms of the Study
Arm 1
Arm 2
Arm Type
Sham Comparator
Experimental
Arm Label
Chemotherapy
Ag-D-CIK
Arm Description
After accepting chemotherapy according to NCCN guidelines, patients will just regularly follow up.
After accepting chemotherapy according to NCCN guidelines,patients will receive 3 cycles of autologous tumor lysate pulsed D-CIK treatment.
Outcomes
Primary Outcome Measures
Progress-free survival
Secondary Outcome Measures
Overall survival
Quality of life (QOL)
Phenotypic analysis of T cells
The number of CD3+ (or CD8+ or CD4+ or CD56+) T cell
Severity of adverse events
According to National Cancer Institute Common Terminology Criteria for Adverse Events（NCI-CTCAE)
Full Information
NCT ID
NCT02215837
First Posted
August 12, 2014
Last Updated
May 23, 2016
Sponsor
Shenzhen Hornetcorn Bio-technology Company, LTD
Collaborators
Affiliated Cancer Hospital & Institute of Guangzhou Medical University, Jingzhou Central Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02215837
Brief Title
Study of Autologous Tumor Lysate-pulsed D-CIK Combined With Chemotherapy for Gastric Cancer
Official Title
Randomized,Controlled,Multicenter Study of Autologous Tumor Lysate-pulsed Dendritic and Cytokine-induced Killer Cells(Ag-D-CIK) Combined With Chemotherapy for Gastric Cancer.
Study Type
Interventional
2. Study Status
Record Verification Date
November 2015
Overall Recruitment Status
Unknown status
Study Start Date
August 2014 (undefined)
Primary Completion Date
May 2018 (Anticipated)
Study Completion Date
May 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shenzhen Hornetcorn Bio-technology Company, LTD
Collaborators
Affiliated Cancer Hospital & Institute of Guangzhou Medical University, Jingzhou Central Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer, Neoplasms, Gastrointestinal Neoplasms, Digestive System Neoplasms, Gastrointestinal Diseases
Keywords
Gastric cancer, D-CIK, Autologous tumor lysate
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Chemotherapy
Arm Type
Sham Comparator
Arm Description
After accepting chemotherapy according to NCCN guidelines, patients will just regularly follow up.
Arm Title
Ag-D-CIK
Arm Type
Experimental
Arm Description
After accepting chemotherapy according to NCCN guidelines,patients will receive 3 cycles of autologous tumor lysate pulsed D-CIK treatment.
Intervention Type
Drug
Intervention Name(s)
Chemotherapy
Other Intervention Name(s)
FOLFOX
Intervention Description
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
Biological
Intervention Name(s)
Ag-D-CIK
Intervention Description
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.
Primary Outcome Measure Information:
Title
Progress-free survival
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Overall survival
Time Frame
3 years
Title
Quality of life (QOL)
Time Frame
3 years
Title
Phenotypic analysis of T cells
Description
The number of CD3+ (or CD8+ or CD4+ or CD56+) T cell
Time Frame
1 years
Title
Severity of adverse events
Description
According to National Cancer Institute Common Terminology Criteria for Adverse Events（NCI-CTCAE)
Time Frame
1 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hai Y Liu, Professor
Organizational Affiliation
Affiliated Tumor Hospital of Guangzhou Medical University immunotherapy center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Affiliated Tumor Hospital of Guangzhou Medical University Immunotherapy center
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510000
Country
China
Facility Name
Jingzhou Central Hospital Immunotherapy center
City
Jingzhou
State/Province
Hubei
ZIP/Postal Code
434020
Country
China
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Study of Autologous Tumor Lysate-pulsed D-CIK Combined With Chemotherapy for Gastric Cancer
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