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Precision Cell Immunotherapy Combined With Chemotherapy in Advanced Gastric Cancer

Primary Purpose

Precision Cell Immunotherapy, Chemotherapy, Advanced Gastric Cancer

Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Chemotherapy
Precision Cell Immunotherapy
Sponsored by
Ningbo Cancer Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Precision Cell Immunotherapy focused on measuring Precision Cell Immunotherapy, Chemotherapy, Advanced Gastric Cancer

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. ECOG score: 0-3;
  4. Advanced Malignancies (gastric cancer) were diagnosed by pathological or clinical physicians;
  5. Enough venous channel, no other contraindications to the separation and collection of white blood cells;
  6. Laboratory examination: white blood cell≥3 x 10*9/L, blood platelet count≥60 x 10*/L,hemoglobin≥85g/L; lymphocyte count≥15%, total bilirubin≤100 mol/L; ALT and AST less than five times of the normal level; serum creatinine less than 1.5 times of the normal level;
  7. Signed informed consent;8. Women of child-bearing age must have evidence of negative pregnancy test and be willing to practice birth control after 2 weeks following the cells transfusion.

Exclusion Criteria:

  1. Expected Overall survival < 6 months;
  2. Patients with uncontrolled hypertension (>160/95mmHg), unstable coronary disease (uncontrolled arrhythmias, unstable angina, decompensated congestive heart failure (> Class II, NYHA), or myocardial infarction within 6 months.
  3. Other serious diseases: nervous, mental disorders, immune regulatory diseases, metabolic diseases, infectious diseases, etc;
  4. Other drugs, or other biological treatment,chemotherapy or radiotherapy are performed within a month.
  5. Unable or unwilling to provide informed consent, or fail to comply with the test requirements.

Sites / Locations

  • Ningbo No.5 Hospital (Ningbo Cancer Hospital)Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Precision Cells combined with Chemotherapy treatment:

Chemotherapy

Arm Description

Precision cells combined with Chemotherapy treatment: Chemotherapy: once a week with a total of six times before 60 days prior to the start of drawing blood. Precision cells:once per 3 weeks with a total of three periods.

Once a week with a total of six times before 60 days prior to the start of drawing blood.

Outcomes

Primary Outcome Measures

Overall survival
Progress-free survival
Quality of life
Questionnaire will be used.

Secondary Outcome Measures

Full Information

First Posted
August 15, 2016
Last Updated
October 6, 2016
Sponsor
Ningbo Cancer Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02873520
Brief Title
Precision Cell Immunotherapy Combined With Chemotherapy in Advanced Gastric Cancer
Official Title
Clinical Study Using Precision Cell Immunotherapy Combined With Chemotherapy in Advanced Gastric Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Unknown status
Study Start Date
August 2016 (undefined)
Primary Completion Date
March 2018 (Anticipated)
Study Completion Date
August 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ningbo Cancer Hospital

4. Oversight

5. Study Description

Brief Summary
To evaluate the safety and effectiveness of cell therapy using Precision Cells to treat Advanced Gastric Cancer. Eligibility: Individuals greater than or equal to 18 years of age and less than or equal to 65 years of age who have been diagnosed with Advanced Gastric Cancer.
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
Precision Cell Immunotherapy, Chemotherapy, Advanced Gastric Cancer
Keywords
Precision Cell Immunotherapy, Chemotherapy, Advanced Gastric Cancer

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
Precision Cells combined with Chemotherapy treatment:
Arm Type
Experimental
Arm Description
Precision cells combined with Chemotherapy treatment: Chemotherapy: once a week with a total of six times before 60 days prior to the start of drawing blood. Precision cells:once per 3 weeks with a total of three periods.
Arm Title
Chemotherapy
Arm Type
Active Comparator
Arm Description
Once a week with a total of six times before 60 days prior to the start of drawing blood.
Intervention Type
Drug
Intervention Name(s)
Chemotherapy
Intervention Description
Cisplatin:60mg/m2,5-FU:500mg/m2,Physiological saline 100ml:IV (in the vein) once a week with a total of six times.
Intervention Type
Biological
Intervention Name(s)
Precision Cell Immunotherapy
Intervention Description
DC cell suspension (1×10*7 DC+physiological saline + 0.25% human bloodalbumin)1ml for each infusion, subcutaneous injection for each infusion, 3 cycles, each cycle received two infusions on day 19, 20; 40, 41; 61, 62. PNAT/PMAT cell suspension (1-6×109 PNAT + physiological saline + 0.25% human bloodalbumin) 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
Title
Progress-free survival
Time Frame
2 years
Title
Quality of life
Description
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; ECOG score: 0-3; Advanced Malignancies (gastric cancer) were diagnosed by pathological or clinical physicians; Enough venous channel, no other contraindications to the separation and collection of white blood cells; Laboratory examination: white blood cell≥3 x 10*9/L, blood platelet count≥60 x 10*/L,hemoglobin≥85g/L; lymphocyte count≥15%, total bilirubin≤100 mol/L; ALT and AST less than five times of the normal level; serum creatinine less than 1.5 times of the normal level; Signed informed consent;8. Women of child-bearing age must have evidence of negative pregnancy test and be willing to practice birth control after 2 weeks following the cells transfusion. Exclusion Criteria: Expected Overall survival < 6 months; Patients with uncontrolled hypertension (>160/95mmHg), unstable coronary disease (uncontrolled arrhythmias, unstable angina, decompensated congestive heart failure (> Class II, NYHA), or myocardial infarction within 6 months. Other serious diseases: nervous, mental disorders, immune regulatory diseases, metabolic diseases, infectious diseases, etc; Other drugs, or other biological treatment,chemotherapy or radiotherapy are performed within a month. Unable or unwilling to provide informed consent, or fail to comply with the test requirements.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bi Wang
Email
biwang0218@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jiangtao Wang
Organizational Affiliation
Ningbo No.5 Hospital (Ningbo Cancer Hospital)
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Huajun Jin
Organizational Affiliation
Shanghai Cell Therapy Research Institute
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Qijun Qian
Organizational Affiliation
Shanghai Cell Therapy Research Institute
Official's Role
Study Chair
Facility Information:
Facility Name
Ningbo No.5 Hospital (Ningbo Cancer Hospital)
City
Ningbo
State/Province
Zhejiang
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bi Wan
Phone
86-13310088259
Email
biwang0218@126.com
First Name & Middle Initial & Last Name & Degree
Jiangtao Wang
Phone
86-15888102792

12. IPD Sharing Statement

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Precision Cell Immunotherapy Combined With Chemotherapy in Advanced Gastric Cancer

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