jRCTc031190107暂停不适用
Randomized phase II clinical trials of S-1 combination WT1 peptide pulse dendritic cells vaccine therapy and S-1 monotherapy for pancreatic cancer following curative resection (PANC-DC/S1)
未提供0 个研究点目标入组 144 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 入组人数
- 144
- 主要终点
- -
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized Controlled Trial
- 干预模型
- Parallel Assignment
- 主要目的
- Prevention Purpose
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 20age old over 至 No limit（—）
- 性别
- All
入选标准
- •Achieving a good understanding of the clinical trial, the patients' role as subjects of the trial, and acquiring a written consent.
- •Patients underwent S-1 as adjuvant postoperative treatment following curative resection. However, they should not have undergone other preoperative treatments.
- •Patients must have a normal oral intake.
- •Patients must be aged 20 years or older at the time of agreement acquisition.
- •Patients' PS (ECOG) must be 0 to
- •When enrolling in the study, individuals should not be participating in other clinical studies.
- •No history of treatment of chemotherapy or radiotherapy in the past 3 years.
- •The cardiovascular system has a sufficient function to undergo apheresis of peripheral-blood mononuclear cells.
- •Sufficient functionality of bone marrow, liver, and the kidneys is maintained. Specifically, the patients must satisfy the following criteria within 14 days of pre-registration.
- •1 White blood cell count >3,000/microL, <12,000/microL
- •2 Hemoglobin >8.0 g/dL
- •3 Platelet >100,000/microL
- •4 Total bilirubin <2.0 mg/dL
- •5 AST <100 IU/L
- •6 ALT <100 IU/L
- •7 Serum creatinine <1.2 mg/dL
- •Negative lab results for HBV, HCV, HTLV-1, HIV, and syphilitic spirochete.
- •Compatibility of HLA typing for the WT1 peptide (with HLA-A 24:02 or HLA-A 02:01).
排除标准
- •When the agreement acquisition conflicts with the following exclusion items, the patient cannot participate to this study. Exclusion criteria are as follows:
- •Patients who preoperatively received chemotherapy or radiotherapy for cancer treatment.
- •Patients who experienced, before registration, any recurrence, peritoneal dissemination, or peritoneal dissemination.
- •Patients for whom immunohistochemistry did not confirm WT 1 expression in the tumor tissue specimen.
- •Patients identified with moderate or severe pleural effusion or ascites fluid by chest X-rays and abdominal CT.
- •Patients with multiple primary cancers.
- •Patients with a history of allergy to OK-432 and penicillin G.
- •Patients with diarrhea, hypertension, and diabetes under poor control.
- •Patients with unstable angina (developing or progression within 3 weeks) or a history of myocardial infarction within 6 months.
- •Presence of a serious heart disorder (e.g., uncontrolled heart failure or arrhythmia). Patients with cerebrovascular disease. Patients with heart failure should match class III or IV in the New York Heart Association functional classification.
- •Patients with severe pulmonary fibrosis or interstitial pneumonia.
- •Patients with serious complications (e.g., heart failure, renal failure, hepatic failure, peptic ulcer, and intestinal paralysis).
- •Patients taking an immunosuppressive drug or an adrenal cortical hormone (more than 10mg/day with conversion of prednisolone).
- •Patients with a serious drug allergy.
- •Patients suspected of having or diagnosed with myelodysplastic syndrome (MDS).
- •Patients with an active infection (except the viral hepatitis) causing a fever of 38 degrees Celsius or higher.
- •Patients requiring transfusion within two weeks pre-registration.
- •Patients undergoing fluoropyrimidine antineoplastic and antifungal agents, phenytoin or flufarin potassium treatments.
- •Patients planning on or currently receiving immune checkpoint inhibitor.
- •Pregnancy or lactation, or women inappropriately performing contraception, or who wish to preserve fertility, or wish to raise a baby.
- •Patients diagnosed with psychosis or psychiatric symptoms, and are judged to have difficulty in participating in the study.
- •Patients diagnosed with an autoimmune disease.
- •Patients who considered a medical attendant inappropriate for any reason .
结局指标
主要结局
-
Relapse free survival (RFS)
次要结局
- Overall survival (OS)
- Immunological monitoring
研究者
相似试验
暂停
不适用
WT1 peptide-pulsed dendritic cell therapy for wet age-related macular degenerationjRCTc03021006810
招募中
1 期
WT1 peptide-pulsed dendritic cell therapy for wet age-related macular degeneratiowet age-related macular degenerationJPRN-jRCTc030210068Gunji Hisato10
已完成
1 期
Immunotherapy using WT1 peptide and a pertussis whole cell vaccine against malignant bone and soft tissue tumors: A phase I/II studyMalignant bone and soft tissue tumorsJPRN-UMIN000010257Department of Orthopaedic Surgery, Kochi Medical School20
已完成
不适用
Immunotherapy using WT1 peptide and a pertussis whole cell vaccine against Head and Neck Tumor: A phase I/II studyHead and Neck TumorJPRN-UMIN000001906Anti-tumor Immunotherapy Research Network, Department of Immunology, Kochi Medical School65
招募中
1 期
Immunotherapy using WT1 peptide and a pertussis whole cell vaccine against recurrent prostate cancer: A phase I/II studyProstate cancerJPRN-UMIN000001821Department of Immunology, Kochi University School of Medicine60