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Immunotherapy Using Pluripotent Killer-Human Epidermal Growth Factor Receptor-2 (PIK-HER2) Cells for the Treatment of Advanced Gastric Cancer With Liver Metastasis

Primary Purpose

Liver Metastasis, Gastric Cancer

Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
PIK-HER2
DC-PMAT
Sponsored by
Second Military Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Liver Metastasis focused on measuring gastric cancer, liver metastasis, PIK-HER2 cells, dendritic cell-precision multiple antigen T cells

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Age 18~65 years old, male or female
  2. Life expectancy > 6 months
  3. Eastern Cooperative Oncology Group (ECOG) score: 0-2
  4. The stomach or gastroesophageal junction carcinoma with hepatic metastasis
  5. Adenocarcinoma
  6. The expression of HER2 in immunohistochemical tumor tissue should be greater than or equal to 2 levels
  7. Creatinine is less than 2.5mg/dL; alanine aminotransferase (ALT) / aspartate aminotransferase(AST)T less than 3 times of the normal; bilirubin is less than 3mg/dL
  8. Blood routine conforms to the requirements of the blood sampling
  9. Signed informed consent
  10. Patients with fertility are willing to use contraceptive method.

Exclusion Criteria:

  1. Expected Overall survival < 6 months
  2. Other serious diseases:the heart,lung,kidney, digestive, nervous, mental disorders, immune regulatory diseases,metabolic diseases, infectious diseases, Etc.
  3. Serum creatinine > 2.5mg/dL;Serum Glutamic Oxaloacetic Transaminase (SGOT) > 5 times of the normal;total bilirubin > 100μmol/L
  4. Without signed informed consent.

Sites / Locations

  • Eastern Hepatobiliary Surgery HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

PIK-HER2 cells

DC-PMAT

Arm Description

PIK-HER2 cells treatment will be performed every 3 weeks with a total of three periods.

DC-PMAT treatment will be performed every 3 weeks with a total of three periods.

Outcomes

Primary Outcome Measures

Overall survival

Secondary Outcome Measures

Progress-free survival
Quality of life
Quality of life core questionnaire will be used.

Full Information

First Posted
December 13, 2015
Last Updated
December 30, 2015
Sponsor
Second Military Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT02632201
Brief Title
Immunotherapy Using Pluripotent Killer-Human Epidermal Growth Factor Receptor-2 (PIK-HER2) Cells for the Treatment of Advanced Gastric Cancer With Liver Metastasis
Official Title
A Clinical Study of Adoptive Cellular Immunotherapy Using Pluripotent Killer T Cells Expressing Antibodies for Human Epidermal Growth Factor Receptor-2 (HER2) in Treating Patients With HER2-Positive Advanced Gastric Cancer With Liver Metastasis
Study Type
Interventional

2. Study Status

Record Verification Date
September 2015
Overall Recruitment Status
Unknown status
Study Start Date
September 2015 (undefined)
Primary Completion Date
March 2017 (Anticipated)
Study Completion Date
September 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Second Military Medical University

4. Oversight

5. Study Description

Brief Summary
Objectives: The purpose of this study is to evaluate the safety and efficacy of PIK-HER2 cells in the treatment of advanced Her2 high expressed gastric cancer with liver metastasis patients. Methods: This study designs a novel therapy using PIK-HER2 cells. 40 Her2 positive patients with liver metastasis from gastric cancer will be enrolled. They are randomly divided into dendritic cell-precision multiple antigen T cells (DC-PMAT) group and PIK-HER2 cells group. Both DC-PMAT treatment and PIK-HER2 cells treatment will be performed every 3 weeks with a total of three periods. The mail clinical indicators are Progression-Free-Survival and Overall Survival.
Detailed Description
A total of 40 patients may be enrolled over a period of 1-2 years.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Metastasis, Gastric Cancer
Keywords
gastric cancer, liver metastasis, PIK-HER2 cells, dendritic cell-precision multiple antigen T cells

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PIK-HER2 cells
Arm Type
Experimental
Arm Description
PIK-HER2 cells treatment will be performed every 3 weeks with a total of three periods.
Arm Title
DC-PMAT
Arm Type
Active Comparator
Arm Description
DC-PMAT treatment will be performed every 3 weeks with a total of three periods.
Intervention Type
Biological
Intervention Name(s)
PIK-HER2
Intervention Description
DC cell suspension (1×107 DC+ physiological saline + 0.25% human serum albumin) 1ml for each infusion, subcutaneous injection for each infusion 3 cycles, each cycle received two infusions on day 19, 20; 40, 41; 61, 62. PIK-HER2 cell suspension (1-6×109 PIK-HER2 + physiological saline + 0.25% human serum albumin) 300ml for each infusion, IV (in the vein) for each infusion 3 cycles, each cycle received one infusions on day 21, 42, 63.
Intervention Type
Biological
Intervention Name(s)
DC-PMAT
Intervention Description
DC cell suspension (1×107 DC+ physiological saline + 0.25% human serum albumin) 1ml for each infusion, subcutaneous injection for each infusion 3 cycles, each cycle received two infusions on day 19, 20; 40, 41; 61, 62. PMAT cell suspension (1-6×109 PMAT + physiological saline + 0.25% human serum albumin) 300ml for each infusion, IV (in the vein) for each infusion 3 cycles, each cycle received one infusions on day 21, 42, 63.
Primary Outcome Measure Information:
Title
Overall survival
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Progress-free survival
Time Frame
2 years
Title
Quality of life
Description
Quality of life core questionnaire will be used.
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 18~65 years old, male or female Life expectancy > 6 months Eastern Cooperative Oncology Group (ECOG) score: 0-2 The stomach or gastroesophageal junction carcinoma with hepatic metastasis Adenocarcinoma The expression of HER2 in immunohistochemical tumor tissue should be greater than or equal to 2 levels Creatinine is less than 2.5mg/dL; alanine aminotransferase (ALT) / aspartate aminotransferase(AST)T less than 3 times of the normal; bilirubin is less than 3mg/dL Blood routine conforms to the requirements of the blood sampling Signed informed consent Patients with fertility are willing to use contraceptive method. Exclusion Criteria: Expected Overall survival < 6 months Other serious diseases:the heart,lung,kidney, digestive, nervous, mental disorders, immune regulatory diseases,metabolic diseases, infectious diseases, Etc. Serum creatinine > 2.5mg/dL;Serum Glutamic Oxaloacetic Transaminase (SGOT) > 5 times of the normal;total bilirubin > 100μmol/L Without signed informed consent.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Qijun Qian, PHD
Phone
+86-21-65580677
Email
qianqj@sino-gene.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Huajun Jin, PHD
Phone
+86-21-81875372
Email
hj-jin@Hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Qijun Qian, PHD
Organizational Affiliation
Eastern Hepatobiliary Surgery Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Eastern Hepatobiliary Surgery Hospital
City
Shanghai
ZIP/Postal Code
200438
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Huajun Jin, PHD
Phone
+86-21-81875372
Email
hj-jin@hotmail.com
First Name & Middle Initial & Last Name & Degree
Qijun Qian, PHD
First Name & Middle Initial & Last Name & Degree
Huajun Jin, PHD
First Name & Middle Initial & Last Name & Degree
Qian Zhang, MD
First Name & Middle Initial & Last Name & Degree
Zhenlong Ye, PHD
First Name & Middle Initial & Last Name & Degree
Lingling Guo, MD
First Name & Middle Initial & Last Name & Degree
Yao Huang, MD

12. IPD Sharing Statement

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Immunotherapy Using Pluripotent Killer-Human Epidermal Growth Factor Receptor-2 (PIK-HER2) Cells for the Treatment of Advanced Gastric Cancer With Liver Metastasis

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