Precision Cell Immunotherapy Combined With Chemotherapy in Advanced Gastric Cancer

Phase 1

• Conditions: Precision Cell Immunotherapy; Chemotherapy; Advanced Malignancies
• Interventions: Drug: Chemotherapy; Biological: Precision Cells

• Registration Number: NCT02862561
• Lead Sponsor: 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.

Detailed Description

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

Study Timeline

• Status Verified: 2016-08
• Study Start: 2016-08
• Study First Submitted: 2016-08-08
• Study First Submitted QC: 2016-08-10
• Study First Posted: 2016-08-11
• Last Update Submitted: 2016-09-01
• Last Update Posted: 2016-09-02
• Primary Completion: 2018-03
• Study Completion: 2018-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Precision Cell Immunotherapy	Chemotherapy	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.
Precision Cell Immunotherapy	Precision Cells	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.
Chemotherapy	Chemotherapy	Chemotherapy: once a week with a total of six times before 60 days prior to the start of drawing blood.

Primary Outcome Measures

Name	Time	Method
Overall survival	2 years
Progress-free survival	2 years

Secondary Outcome Measures

Name	Time	Method
Quality of life	2 years

Trial Locations

Locations (1)

Shanghai International Medical Center; 🇨🇳 Shanghai, Shanghai, China