NL-OMON45223已完成不适用
Phase I Study: safety and immunogenicity of vaccination with XAGE1B long peptides combined with poly-ICLC in patients with pulmonary adenocarcinoma - XAGE trial
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •For stage I&II pulmonary adenocarcinoma patients:
- •* Histologically proven pulmonary adenocarcinoma stage I or II according to recent guidelines on TNM classification of NSCLC
- •* Age * 18 years
- •* Completion of curative resection or SBRT and adjuvant chemotherapy or radiotherapy if necessary according to guidelines.
- •* Good WHO performance status (0-2)
- •* Adequate bone marrow function: WBC * 2.0 x 109/l, platelets > 100 x 109/l, hemoglobin > 5.0 mmol/L
- •* Survival expectation > 3 months
- •* Written informed consent according to the local Ethics Committee requirements;For stage III pulmonary adenocarcinoma patients:;* Histologically proven pulmonary adenocarcinoma stage IIIb according to recent guidelines on TNM classification of NSCLC.
- •* Age * 18 years
- •* Completion of standard chemo-radiotherapy
- •* No intention for further chemotherapy treatment
- •* Good WHO performance status (0-2)
- •* Adequate bone marrow function: WBC * 2.0 x 109/l, platelets > 100 x 109/l, hemoglobin > 5.0 mmol/L
- •* Survival expectation > 3 months
- •* Written informed consent according to the local Ethics Committee requirements;For stage IV pulmonary adenocarcinoma patients:
- •* Histologically proven pulmonary adenocarcinoma stage IV according to recent guidelines on TNM classification of NSCLC 1.
- •* Age * 18 years
- •* Completion of standard (platinum-based) chemotherapy schedules with no intention for further chemotherapy treatment
- •* Good WHO performance status (0-2)
- •* Adequate bone marrow function: WBC * 2.0 x 109/l, platelets > 100 x 109/l, hemoglobin > 5.0 mmol/L
- •* Survival expectation > 3 months
- •* Written informed consent according to the local Ethics Committee requirements
排除标准
- •* Progressive disease after finishing standard treatment
- •* Inadequate bone marrow function more than 3 weeks after last chemotherapy treatment.
- •* Poor WHO performance status (3-5)
- •* Eligibility for treatment with Tyrosine Kinase Inhibitors (e.g. erlotinib)
- •* History of an autoimmune disease or other systemic intercurrent disease that might affect the immunocompetence of the patient, or patients receiving immunosuppressive therapy including transplant recipients
- •* Second primary tumor of non-pulmonary origin
- •* CD4 cell count < 200/m3 at baseline
- •* Known seropositivity for Hepatitis B Virus and/or HIV
- •* History of serious liver or kidney dysfunction, heart condition or thyroid disorder
- •* Pregnancy or Lactating
- •* Known hypersensitivity reaction to any of the components used during treatment
- •* Medical or psychological condition which in the opinion of the treating chest physician and investigator would not permit the patient to participate in or to complete the study
研究者
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