Phase Ib/II clinical trial of individualized adjuvant immunotherapy with new antigen reactive immune cells (NRT) in gastric signet-ring cell carcinoma

Status

Recruiting

Phases

Phase 2

Study type

Observational

Source

ChiCTR

Registry ID

ChiCTR-OIC-17011913

Enrollment

Unknown

Registered

2017-07-09

Start date

2017-07-10

Completion date

Unknown

Last updated

2017-07-10

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

Conditions

gastric signet-ring cell carcinoma

Interventions

NRT:NRT immunotherapy

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 signet-ring cell carcinoma (poorly cohensive 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

Measure	Time frame
mDFS;immunology indexes;	—

Secondary

Measure	Time frame
Safety;Serum markers;	—

Countries

China

Contacts

Public ContactBaorui Liu

The Affiliated Drum Tower Hospital to Medical School of Nanjing University

baoruiliu@nju.edu.cn+86 13770621908

Outcome results

None listed

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