Phase I/II Trial of Tumor Vaccine in Post Radical Operation Patients With Lung Cancer
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Disease-free Survival (DFS)
研究概览
简要总结
Tumor vaccines may make the body build an immune response to kill tumor cells. This research study is evaluating a new type of tumor vaccine termed as "Neoantigen Tumor Vaccine". The purpose of this phase I/II trial study is to assess the safety and effectiveness of neoantigentumor vaccine in post radical operation patients with stage IIIA lung cancer.
详细描述
Outline: After successful vaccine manufacturing, patients receive neoantigen tumor vaccine hypodermically (5 injections for each 3 days and then 1 injection for each 3 months till recurrence or up to 2 years). Treatment continues in the absence of disease recurrence and metastasis or unacceptable toxicity.
Patients are followed for 2 years or up to the absence of disease recurrence and metastasis.
Projected accrual: A total of 30 patients will be accrued for this study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 18 to 70 years, Male or Female
- •Histological or cytologically diagnosis of lung adenocarcinoma
- •After surgical treatment (lobectomy and systematic lymph node dissection)
- •Pathological stage IIIA (According to the IASLC Lung Cancer Staging (eight Edition))
- •Postoperative standard treatment (platinum-based double-drug adjuvant treatment with or without chemotherapy) or no adjuvant treatment
- •Have potential dynamic tumor biomarkers
- •Able and willing to give witnessed, written informed consent form prior to receiving any study related procedure, agree to participate in long-term follow-up for up to 3 years
排除标准
- •Age < 18 or< 70 years
- •Lung squamous cell carcinoma, small cell lung cancer, large cell lung cancer
- •Without surgical treatment
- •Pathological stage I、II、IIIB、IIIC or IV (According to the IASLC Lung Cancer Staging (eight Edition))
- •Participation in any other clinical trial involving another investigational agent within 4 weeks prior to first dose of study vaccine
- •Drug or alcohol abusers
- •Pregnant or breast-feeding patients
- •History of immunodeficiency disease or autoimmune disease
- •Patients with chronic disease which is undergoing immune reagents or hormone therapy
- •Concurrent other medical condition that would prevent the patient from undergoing protocol-based therapy
- •Lack of availability of a patient for immunological and clinical follow-up
结局指标
主要结局
Disease-free Survival (DFS)
时间窗: Approximately 2 years
The time that participants stay free of cancer after surgery following administration of tumor vaccine
Adverse Events (AEs)
时间窗: 30 days from first study vaccine administration
Number of participants experiencing clinical and laboratory adverse events
次要结局
未报告次要终点
研究者
Yongchang Zhang
MD, pHD, Director of Thoracic Surgery Department II
Hunan Province Tumor Hospital