None listed
Conditions
Sponsors
Dongnam Institute of Radiological & Medical Sciences
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: ? Males or females aged 20 years or older ? Patients who have undergone curative resection after being diagnosed histologically with non-metastatic gastric adenocarcinoma (stage II–III) ? Patients with an autologous (frozen) tumor tissue sample for gastric cancer ? Patients who have completed curative resection and adjuvant treatment for advanced gastric cancer within the last 3–12 weeks - Standard adjuvant treatment: S-1 therapy or XELOX therapy S-1 therapy: S-1 administered twice per day at the following doses for Days 1–28, repeated at 6-week intervals for 1 year <1.25 m2: 40 mg per dose, =1.25 m2 and <1.5 m2: 50 mg per dose, =1.5 m2: 60 mg per dose. XELOX therapy: Capecitabine 1000 mg/m2 twice per day for days 1–14 Oxaliplatin 130 mg/m2 on day 1, repeated at 3-week intervals for 6 months ? Among patients unable to receive adjuvant therapy after curative resection for advanced gastric cancer, those who received curative resection within the last 3–12 weeks - Elderly patients (>70 years old) who refused adjuvant therapy - Patients contraindicated for the standard adjuvant chemotherapy agents S-1 or XELOX (capecitabine, oxaliplatin) ? Contraindications for S-1: Patients with a history of severe S-1 hypersensitivity, patients currently being administered other fluoropyrimidines, patients currently being administered flucytosine ? Contraindications for capecitabine: Patients with a history of capecitabine hypersensitivity, patients who show a severe reaction to fluoropyrimidines or fluoruracil hypersensitivity, patients taking combination sorivudine/brivudine, patients with DPD deficiency, patients taking combination tegafur/gimeracil/oteracil potassium currently or who stopped in the last 7 days ? Contraindications for oxaliplatin: Patients with a history of hypersensitivity to oxaliplatin or other platinum-containing drugs, patients with peripheral sensory neuropathy showing functional injury before the first cycle ? Patients with an ECOG score of 0–2 for performance status ? Patients satisfying the following conditions - Hematologic function: WBC count =3,000/µL, ANC =1,500/µL, - Platelet count =75,000/µL, hemoglobin =9.0 mg/dL - Hepatic function: bilirubin =1.5-fold the normal values, ALT and AST =2.5-fold the normal values - Renal function: creatinine =1.5 mg/dL ? Among fertile patients, those consenting to the use of appropriate contraception ? Among female patients who may be patient, those showing a negative result in urine HCG tests 7 days before registration ? Individuals who sign the participant consent form and consent to the trial and follow-up procedures
Exclusion criteria
Exclusion criteria: ? Patients who have received other types of immunotherapy in the last year ? Patients for whom the planned dose of test drug cannot be prepared because of difficulty in obtaining a sufficient amount of autologous tumor tissue ? Patients with uncontrolled autoimmune disease or severe internal disease (severe infection, heart disease, etc.) ? Patients with uncontrolled central nervous system or psychiatric disability ? Patients who have been diagnosed with multiple active primary cancer in the last 5 years, excluding properly treated cervical carcinoma in situ, basal or squamous cell carcinoma of the skin, and thyroid cancer ? HIV-positive patients ? Patients who have been treated for tuberculosis within the last year ? Pregnant or breastfeeding women ? Patients who are regularly administered corticosteroids (or equivalent; excluding medication for acute hypersensitivity reaction, or patients who are being administered a low dose (=20 mg methylprednisolone or equivalent) for at least 6 months before being administered the test drug in this study) ? Patients contraindicated for or requiring caution when taking cyclophosphamide - Patients being administered pentostatin; patients with a history of infectious disease, severe bone marrow depression, cystitis, urinary tract obstruction, or hypersensitivity to the drug’s ingredient; pregnant or breastfeeding women; and patients with severe liver or kidney dysfunction - Patients with varicella ? Patients who have been judged to be unsuitable as a clinical trial participant by another researcher - Patients who are certain to drop out of the study or who are unavailable for long-term follow-up for any of the following reasons: psychological, social, family, or geographical reasons, or difficulty adhering to the proper follow-up procedures or the clinical study plan - Patients with uncontrolled hepatitis, chronic liver disease, or diabetes - Patients who were considered to be unsuited to participating in this trial by their attending physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safey(Adverse event, concomitant medication, Labaratory test result);Efficacy(Disease free survival, Overall survival) | — |
Secondary
| Measure | Time frame |
|---|---|
| Immun reactio test (Delayed-Type Hypersensitivity Test: DTH);Interferon Gamma Detection Assay | — |
Countries
Korea, Republic of
Contacts
Public ContactMiyoung Kim
Dongnam Institute of Radiological & Medical Sciences
Outcome results
None listed