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Status unknownNCT02862561Updated Sep 2, 2016

Precision Cell Immunotherapy Combined With Chemotherapy in Advanced Gastric Cancer

A Phase 1/2 interventional study of Chemotherapy and Precision Cells in Precision Cell Immunotherapy, Chemotherapy and Advanced Malignancies, sponsored by Shanghai International Medical Center. Status unknown at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2016-09-02.

Sponsored by Shanghai International Medical Center · Phase 1/2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Aug 2016), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 1/2
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

Read the detailed description

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

02

Conditions studied

  • Precision Cell Immunotherapy
  • Chemotherapy
  • Advanced Malignancies

Keywords

  • Precision Cell Immunotherapy
  • Chemotherapy
  • Advanced Malignancies
03

In context

Lead sponsor

Shanghai International Medical Center is the lead sponsor of 4 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
40 participants (estimated)

Study arms

  • 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 · Biological: Precision Cells

  • 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

Interventions

  • DrugChemotherapy

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

  • BiologicalPrecision 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.

06

What researchers measure

Primary outcomes

  1. Overall survival

    Time frame: 2 years

  2. Progress-free survival

    Time frame: 2 years

Secondary outcomes

  1. Quality of life

    Time frame: 2 years

07

Study locations

1 of 1 sites recruiting
  • Shanghai International Medical Center
    Shanghai, Shanghai Municipality 201318, China
    Recruiting
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Aug 2016, a primary completion of Mar 2018 and a completion of Jul 2018. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 8, 2016
First posted
Aug 11, 2016
Start
Aug 2016
Primary completionEst.
Mar 2018
CompletionEst.
Jul 2018
Last update
Sep 2, 2016
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 2, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02862561
Lead sponsor
Shanghai International Medical Center
Responsible party
Sponsor
First posted
Aug 11, 2016
Start date
Aug 2016
Primary completion
Mar 2018 (estimated)
Completion
Jul 2018 (estimated)
Last update
Sep 2, 2016

Study contacts

Naiyan Han
Contact
naiyan.han@simcgroup.com
+86 21 6023 6666
Naiyan Han
study chair · Shanghai International Medical Center
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Aug 2016. You cannot join it, but the record below documents what was studied.

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