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Precision Cell Immunotherapy Combined With Chemotherapy in Advanced Gastric Cancer

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ClinicalTrials.gov Identifier: NCT02862561
Recruitment Status : Unknown
Verified August 2016 by Shanghai International Medical Center.
Recruitment status was:  Recruiting
First Posted : August 11, 2016
Last Update Posted : September 2, 2016
Sponsor:
Information provided by (Responsible Party):
Shanghai International Medical Center

Brief Summary:

Objectives:

To evaluate the safety and effectiveness of cell therapy using Precision Cell Immunotherapy 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.


Condition or disease Intervention/treatment Phase
Precision Cell Immunotherapy Chemotherapy Advanced Malignancies Drug: Chemotherapy Biological: Precision Cells Phase 1 Phase 2

Detailed Description:
A total of 40 patients may be enrolled over a period of 1-2 years.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Study Using Precision Cell Immunotherapy Combined With Chemotherapy in Advanced Gastric Cancer
Study Start Date : August 2016
Estimated Primary Completion Date : March 2018
Estimated Study Completion Date : July 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer

Arm Intervention/treatment
Experimental: Precision Cell Immunotherapy

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.

Drug: Chemotherapy
Cisplatin:60mg/m2,5-FU:500mg/m2,Physiological saline 100ml:IV (in the vein) once a week with a total of six times.

Biological: Precision Cells
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. Precision cells suspension (1-6×109 Precision cells + 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.

Active Comparator: Chemotherapy

Chemotherapy:

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

Drug: Chemotherapy
Cisplatin:60mg/m2,5-FU:500mg/m2,Physiological saline 100ml:IV (in the vein) once a week with a total of six times.




Primary Outcome Measures :
  1. Overall survival [ Time Frame: 2 years ]
  2. Progress-free survival [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. Quality of life [ Time Frame: 2 years ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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;
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02862561


Contacts
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Contact: Naiyan Han +86 21 6023 6666 naiyan.han@simcgroup.com

Locations
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China, Shanghai
Shanghai International Medical Center Recruiting
Shanghai, Shanghai, China, 201318
Contact: Naiyan Han    +86 (0) 182 1766 2469    naiyan.han@simcgroup.com   
Sponsors and Collaborators
Shanghai International Medical Center
Investigators
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Study Chair: Naiyan Han Shanghai International Medical Center

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Responsible Party: Shanghai International Medical Center
ClinicalTrials.gov Identifier: NCT02862561     History of Changes
Other Study ID Numbers: SIMC-20160105
First Posted: August 11, 2016    Key Record Dates
Last Update Posted: September 2, 2016
Last Verified: August 2016
Keywords provided by Shanghai International Medical Center:
Precision Cell Immunotherapy
Chemotherapy
Advanced Malignancies
Additional relevant MeSH terms:
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Neoplasms
Immunologic Factors
Physiological Effects of Drugs