KCT0002944招募中未知
Study of immunologic responses and safety of autologous dendritic cells in advanced gastric cancer patients following curative resection
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 入组人数
- 50
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 20(Year) 至 o Limit（—）
- 性别
- All
入选标准
- •? 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
排除标准
- •? 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
研究者
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