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Phase Ib/II clinical trial of individualized adjuvant immunotherapy with new antigen reactive immune cells (NRT) in gastric cancer

Phase Ib/II clinical trial of individualized adjuvant immunotherapy with new antigen reactive immune cells (NRT) in gastric cancer

Status
Recruiting
Phases
Phase 2
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR-OIC-16010092
Enrollment
Unknown
Registered
2016-12-06
Start date
2016-12-05
Completion date
Unknown
Last updated
2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

gastric cancer

Interventions

Sponsors

The Drum Tower Hospital Affiliated to Medical College of Nanjing University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Female or male aged 18 to 75 years; 2. Histologic or cytologic confirmation of advanced gastric carcinoma; 3. Patients without measurable lesions after surgery, and stage II-III (AJCC 7th); 4. Child-pugh A-B; 5. ECOG<0-2; 6. Patients had not received systemic venous chemotherapy ever before; 7. Hematology Index; 8. Neutrophile granulocyte greater than 1.5×10^9/L; 9. Hemoglobin greater than 10g/dL; 10. Platelet greater than 90×10^9/L; 11. Biochemical index; 12. Serum bilirubin not greater than 1.5x upper limit of reference range (ULN); 13. ALT or AST not greater than 1.5x ULN; 14. Creatinine clearance no less than 60ml/min; 15. Negative pregnancy test for women of childbearing potential; 16. Provision of informed consent; 17. Be able to follow the research program and follow up process; 18. Expected survival time 3 months or more.

Exclusion criteria

Exclusion criteria: 1. Chemotherapy with experimental drug within 2 months before the start of study therapy; 2. Have at least another primary malignant tumor; 3. Active infection with bacterial or fungal infection; 4. Patients with HIV infection, HCV infection, serious coronary artery disease or asthma, serious cerebrovascular disease or other diseases that the researchers think can not be entered into the group; 5. Women who are pregnant or breast feeding; 6. Drug abuse, clinical or psychological or social factors which will influence the informed consent or the study implementation; 7. May be allergic to immunotherapy; 8. Radiotherapy and immunotherapy may not be implemented due to social or geographical factors; 9. Weight loss greater 10% within 6 weeks before the start of study therapy; 10. influence the safety or compliance of the patients.

Design outcomes

Primary

MeasureTime frame
mDFS;immunology indexes;

Secondary

MeasureTime frame
Serum markers;safety;

Countries

China

Contacts

Public ContactBAORUI LIU

The Drum Tower Hospital Affiliated to Medical College of Nanjing University

baoruiliu@nju.edu.cn+86 13770621908

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Mar 3, 2026