Precision Cell Immunotherapy Combined With Chemotherapy in Advanced Gastric Cancer

Chemotherapy Clinical Trial

Official title:

Clinical Study Using Precision Cell Immunotherapy Combined With Chemotherapy in Advanced Gastric Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02862561
• Other study ID #: SIMC-20160105
• Status: Recruiting
• Phase: Phase 1/Phase 2
• First received: August 8, 2016
• Last updated: September 1, 2016
• Start date: August 2016
• Est. completion date: July 2018

Study information

• Verified date: August 2016
• Source: Shanghai International Medical Center
• Contact: Naiyan Han
• Phone: +86 21 6023 6666
• Email: naiyan.han[@]simcgroup.com
• Is FDA regulated: No
• Health authority: China: Ethics Committee:Shanghai International Medical Center Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: July 2018
• Est. primary completion date: March 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Advanced Malignancies
• Chemotherapy
• Neoplasms
• Precision Cell Immunotherapy
• Stomach Neoplasms

Intervention

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.

Locations

Country	Name	City	State
China	Shanghai International Medical Center	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai International Medical Center

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival		2 years	No
Primary	Progress-free survival		2 years	No
Secondary	Quality of life		2 years	No