NCT02873520

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Aug 2016

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2016

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

August 15, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 19, 2016

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2018

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2018

Completed
Last Updated

October 7, 2016

Status Verified

August 1, 2016

Enrollment Period

1.6 years

First QC Date

August 15, 2016

Last Update Submit

October 6, 2016

Conditions

Precision Cell ImmunotherapyChemotherapyAdvanced Gastric Cancer

Keywords

Precision Cell ImmunotherapyChemotherapyAdvanced Gastric Cancer

Outcome Measures

Primary Outcomes (3)

  • Overall survival

    2 years

  • Progress-free survival

    2 years

  • Quality of life

    Questionnaire will be used.

    2 years

Study Arms (2)

Precision Cells combined with Chemotherapy treatment:

EXPERIMENTAL

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: ChemotherapyBiological: Precision Cell Immunotherapy

Chemotherapy

ACTIVE COMPARATOR

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

Drug: Chemotherapy

Interventions

ChemotherapyDRUG

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

ChemotherapyPrecision Cells combined with Chemotherapy treatment:
Precision Cell ImmunotherapyBIOLOGICAL

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.

Precision Cells combined with Chemotherapy treatment:

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ningbo No.5 Hospital (Ningbo Cancer Hospital)

Ningbo, Zhejiang, China

RECRUITING

MeSH Terms

Interventions

Drug Therapy

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • Jiangtao Wang

    Ningbo No.5 Hospital (Ningbo Cancer Hospital)

    STUDY DIRECTOR

  • Huajun Jin

    Shanghai Cell Therapy Research Institute

    STUDY CHAIR

  • Qijun Qian

    Shanghai Cell Therapy Research Institute

    STUDY CHAIR

Central Study Contacts

Bi Wang

CONTACT

biwang0218@126.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 15, 2016

First Posted

August 19, 2016

Study Start

August 1, 2016

Primary Completion

March 1, 2018

Study Completion

August 1, 2018

Last Updated

October 7, 2016

Record last verified: 2016-08

Locations

CN(1)