Study of immunologic responses and safety of autologous dendritic cells in advanced gastric cancer patients following curative resectio
- Conditions
- Neoplasms
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 50
? 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
? 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
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safey(Adverse event, concomitant medication, Labaratory test result);Efficacy(Disease free survival, Overall survival)
- Secondary Outcome Measures
Name Time Method Immun reactio test (Delayed-Type Hypersensitivity Test: DTH);Interferon Gamma Detection Assay