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A randomized controlled trial for evaluation of the effect of a novel dendritic cell vaccine on patients with middle-low differentiated adenocarcinoma of gastric after operation

A randomized controlled trial for evaluation of the effect of a novel dendritic cell vaccine on patients with middle-low differentiated adenocarcinoma of gastric after operation

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1800015576
Enrollment
Unknown
Registered
2018-04-09
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

Experiment Group:DC vaccine combined with routine treatment
Control Group:conventional therapy

Sponsors

Lanzhou University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: (1) Aged=18 years old; (2) patients with gastric cancer according to the NCCN guideline (2017.V5); (3) surgical resection of the tumor; (4) ECOG score between 0 and 2 or KPS higher than 70; (5) criteria of the laboratory examination results within 1 as follow: 1) the white blood cells (WBC) =3×10^9/L; 2) platelet (PLT)=80 x 10^9/L, hemoglobin (Hb)=80g/L; 3) total bilirubin (TBI) = 1.5x normal level (2mg/dl); 4) alanine aminotransferase (ALT), glutamate transaminase (AST) = 2 x normal level; 5) creatinine (Cr) = 1.5x normal value; 6) coagulation parameters (PT, APTT in normal range); (6) voluntarily signed informed consent.

Exclusion criteria

Exclusion criteria: (1) serious uncontrolled medical diseases, viral hepatitis, organ dysfunction and myocardial infarction (during 3 months); (2) the patients combine with heart, kidney and lung diseases were determined: 1) three or higher levels of cardiopulmonary dysfunction and severe renal disease (refer to CTCAE4.0 criteria); 2) previous diagnosis of coronary heart disease, myocardial ischemia, myocardial infarction, arrhythmia (atrial tachycardia, atrial fibrillation, continuous ventricular tachycardia,et al.); (3) patients who are using immunosuppressive drugs or long-term immunosuppressive agents after organ transplantation; (4) the human immunodeficiency virus (HIV) tested positive for active infection within 30 days before treatment, including fever of unknown cause (axillary temperature >37); (5) breast-feeding, pregnant women or planned pregnancy; (6) the patients participate in other clinical trialsenter clinical within 30 days; (7) patients with t-cell lymphoma; (8) patients with severe autoimmune diseases; (9) patients with allergies, especially those with il-2; (10) recent history of active bleeding; (11) mental illness and severe depression.

Design outcomes

Primary

MeasureTime frame
overall survival;progression free survival;Tumor markers;Peripheral blood lymphocyte subsets;Karnofsky Performance Scale Index;Tumor lesions assessment;Vital signs;Blood Routine Test;Urine Routine Test;

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