Precision Cell Immunotherapy Combined With Chemotherapy in Advanced Gastric Cancer

Shanghai International Medical Center

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Precision Cell Immunotherapy; Advanced Malignancies; Chemotherapy

Treatments: Biological: Precision Cells; Drug: Chemotherapy

Study type: Interventional

Funder types: Industry

Identifiers

NCT02862561

SIMC-20160105

Details and patient eligibility

About

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.

Full description

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

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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;
• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Precision Cell Immunotherapy

Experimental group

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.

Treatment:

Biological: Precision Cells

Drug: Chemotherapy

Chemotherapy

Active Comparator group

Description:

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

Treatment:

Drug: Chemotherapy