A Randomized, Controlled, Open-label, Single Center, Phase II Study to Evaluate the Efficacy and Safety of NK Cell-based Immunotherapy as Maintenance Therapy for Patients With Small-cell Lung Cancer After First-line Chemotherapy.
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Progression-free survival(PFS)
研究概览
简要总结
Natural killer (NK) cells can kill a broad array of tumor cells in a non-major histocompatibility complex(MHC)-restricted manner. Adoptive transfer of NK may prolong the survival of patients with cancer. This study evaluates the efficacy and safety of NK cell-based immunotherapy for small-cell lung cancer (SCLC) after first-line chemotherapy. Half of the participants will receive autologous adoptive transfer of NK cells after the response from first-line chemotherapy, while the other half will be followed up in routine clinal practice.
详细描述
The small-cell lung cancer (SCLC) is very sensitive to the standard-of-care first-line chemotherapy and/or radiotherapy, but it will ultimately progress or relapse and develop early resistance to conventional treatments. No effective maintenance therapy except for wath and wait after first-line therapy at present.
NK cells constitute the major component of the innate immune system and kill tumor cells in a non-MHC-restricted manner. In our previous pilot study and other reports, adoptive transfer of autologous NK cells expanded ex vivo was very well tolerant and effective.
There is no prospective trial on the maintenance therapy of SCLC after first-line chemotherapy based on autologous NK cells. The purpose of this phase II clinical research is to evaluate the efficacy and safety of autologous NK cells as the maintenance therapy after the first-line treatment, comparing with conventional observation group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically or cytologically confirmed small cell lung cancer.
- •Having completed first-line therapy in the presence of stable disease (SD), partial remission (PR) or complete remission (CR) status.
- •Age ≥18 years.
- •Karnofsky Performance Status (KPS) ≥
- •Important organs:cardiac ejection fraction >50%; Pulse Oxygen Saturation(SpO2) >90%; creatinine (Cr) ≤ 2.5 times the normal range; alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3 times the normal range, total bilirubin (TBIL)≤2.0mg/dl (34.2umol/L);Hgb≥60g/L.
- •Without contraindication of apheresis and cell isolation.
- •Patients and their families having the willingness to participate in clinical trial with signed written informed consent.
排除标准
- •Patient having an active rheumatic immunologic disease.
- •Uncontrolled bacterial, fungal or viral infection.
- •human immunodeficiency virus(HIV), hepatitis B virus infection(HBV), hepatitis C virus(HCV) infection.
- •History of organ transplantation and hemopoietic stem cell transplantation.
- •Pregnant or lactating women.
- •Patients using immunosuppressive agents within the first 3 months of the study or received glucocorticoid systemic therapy within a week prior to entry into the study.
- •Patients receiving other immunotherapy after diagnosis.
研究组 & 干预措施
routine follow-up
According to present guideline, no special treatment is advised for patients with SCLC after first-line therapy.They will be followed-up regularly.
autologous natural killer cells
Infusion of 1-2×10^9 NK cells every 14 days in the absence of progression or unacceptable toxicity until the 6 courses of treatment.
干预措施: NK cells (Biological)
结局指标
主要结局
Progression-free survival(PFS)
时间窗: 20 months
Progression-free survival is defined as the time from randomization to first observation of progression or date of death (from any cause). Progression will be evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1. Patients who do not progress or not die will be censored on the date of their last tumor assessment, i.e. on the last date that we really know that the patient is considered as "progression-free".
次要结局
- Overall survival(OS)(20 months)
- Evaluate the change of the quality of life for all patients(20 months)
研究者
jiuwei cui
chief
The First Hospital of Jilin University