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A randomized controlled trial for the efficacy of a novel dendritic cell vaccine which loading with tumor membrane proteins in the treatment of distal advanced gastric cancer patients

A randomized controlled trial for the efficacy of a novel dendritic cell vaccine which loading with tumor membrane proteins in the treatment of distal advanced gastric cancer patients

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1800015708
Enrollment
Unknown
Registered
2018-04-16
Start date
2018-05-01
Completion date
Unknown
Last updated
2018-04-30

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

Conditions

gastric cancer

Interventions

experimental group:DC-CIK immunothreapy which pulsed with gastric tumor membrane proteins

Sponsors

Lanzhou University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Post-operation pathologically confirmed distal gastric cancer patients; 2. Aged 18-70 years old; 3. ECOG physical status score 0-2 or KPS = 70 points; 4. The results of laboratory tests in the last week meet the following conditions: Neutrophil (ANC) =1.5×10^9/L; Platelet (PLT) = 80×10^9/L, hemoglobin (Hb) = 80g/L; Total bilirubin (TBI) =1.5×upper limit of normal (2mg/dl); Alanine aminotransferase (ALT), aspartate aminotransferase (AST) = 2 × upper limit of normal; Creatinine (Cr) = 1.5 × upper limit of normal; Coagulation parameters (INR and PTI in the normal range); 5. Patients volunteered and signed informed consent.

Exclusion criteria

Exclusion criteria: 1. Severe cardiovascular and cerebrovascular diseases, diabetes, organ dysfunction and recent history of myocardial infarction (3 months); 2. HIV infection, viral hepatitis; 3. Acute infection, and severe infection uncontrolled or fever patients; 4. Pregnant or lactating women; 5. Severe autoimmune disease patients; 6. Patients who are using immunosuppressive drugs or long-term immunosuppressants after organ transplantation; 7. T-cell lymphoma patients; 8. Allergies, especially those with IL-2 allergies; 9. Serious liver and kidney dysfunction; 10. Serious coagulation disorders; 11. Stubborn or persistent epilepsy; 12. Mental illness and severe depression; 13. Researchers think it is not suitable for enrollment.

Design outcomes

Primary

MeasureTime frame
Tumor lesions assessment;lymphocyte subsets;tumor markers test;

Secondary

MeasureTime frame
blood tests, urine tests, blood biochemistry;KPS;ECOG score;short-term efficacy;

Countries

China

Contacts

Public ContactYu-min Li

Lanzhou University

liym@lzu.edu.cn+86 13893615421

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026