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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

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:

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.

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

NCT ID

NCT02873520

First Posted

August 15, 2016

Last Updated

October 6, 2016

Sponsor

Ningbo Cancer Hospital

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

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

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

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

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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