A Prospective Phase II Controlled Study to Evaluate the Impact of Thymosin Alpha 1 on the Completion Rate of Consolidation Immunotherapy After Radical Radiochemotherapy for Locally Advanced Non-Small Cell Lung Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 114
- 试验地点
- 2
- 主要终点
- Completion rate of immunotherapy
研究概览
简要总结
This prospective phase II randomized study is to determine the impact of thymosin alpha-1 on the concurrent chemoradiotherpay followed by immunotherapy consolidation in patients with locally advanced NSCLC by assessing the survival outcomes, treatment responses and toxicities.
详细描述
This prospective phase II randomized study is to determine the impact of thymosin alpha-1 on the concurrent chemoradiotherpay followed by immunotherapy consolidation in patients with locally advanced NSCLC by assessing the survival outcomes, treatment responses and toxicities.
Patients with locally advanced NSCLC who will receive concurrent radiochemotherapy followed by immunotherapy consolidation will be randomly divided into two groups (concurrent Tα1 treatment group and control group [in which Tα1 will not be used]), and the overall survivals, progression-free survivals (PFS), completion rate of immunotherapy consolidation, toxicities/adverse effects, and peripheral blood immune biomarkers will be compared between these two groups.
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
- •aged ≥18 years old
- •histologically confirmed locally advanced and unresectable NSCLC;
- •no prior radiotherapy or surgery;
- •with the life expectancy over 12 weeks;
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
- •adequate bone marrow and hepatic and renal functions;
- •informed consent
排除标准
- •Concurrent enrollment in another clinical trial, unless it is an observational (non-interventional) clinical study;
- •With histologically documented combined small-cell lung carcinoma;
- •Major surgery (excluding vascular access placement) within 4 weeks prior to enrollment in the study;
- •Active or prior documented autoimmune disease within the past 2 years;
- •Active or prior documented inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis);
- •History of innate immunodeficiency;
- •History of organ transplant that requires the use of immunosuppressives;
- •A mean heart rate-corrected QT interval (QTc) ≥ 470 ms, calculated using Bazett correction from 3 ECG calculation cycles;
- •Poorly managed health conditions that include but are not limited to persistent or active infections, symptomatic congestive heart failure, poorly controlled hypertension, unstable angina, arrhythmia, active peptic ulcer disease or gastritis, active hemorrhagic diseases, hepatitis C or human immunodeficiency virus (HIV) infection, hepatitis B (positive HBsAg and HBV DNA > 500 IU/ml), and mental disorders/social conditions that may hinder the compliance with the study requirements or the ability to give written informed consent willingly;
- •Active tuberculosis;
- •Receipt of live or attenuated vaccination within 30 days prior to the first dose of the investigational agents;
- •History of another primary malignancy within the past 5 years, excluding adequately treated basal or squamous cell skin cancers or cervical carcinoma in situ;
- •Pregnant/breastfeeding women or males/females of reproductive potential who do not use contraception.
研究组 & 干预措施
Concurrent Tα-1 group
In this concurrent Tα-1 group, participants receive concurrent chemoradiotherapy followed by immunotherapy consolidation. During this treatment, thymosin alpha-1 was administered at 4.8mg each time.
干预措施: concurrent chemotherapy (Drug)
Concurrent Tα-1 group
In this concurrent Tα-1 group, participants receive concurrent chemoradiotherapy followed by immunotherapy consolidation. During this treatment, thymosin alpha-1 was administered at 4.8mg each time.
干预措施: Immunotheapy consolidation (Drug)
Control group
In control group, participants receive concurrent chemoradiotherapy followed by immunotherapy consolidation.
干预措施: definitive radiotherapy (Radiation)
Control group
In control group, participants receive concurrent chemoradiotherapy followed by immunotherapy consolidation.
干预措施: induction chemo-immunotherapy (Drug)
Control group
In control group, participants receive concurrent chemoradiotherapy followed by immunotherapy consolidation.
干预措施: concurrent chemotherapy (Drug)
Control group
In control group, participants receive concurrent chemoradiotherapy followed by immunotherapy consolidation.
干预措施: Immunotheapy consolidation (Drug)
Concurrent Tα-1 group
In this concurrent Tα-1 group, participants receive concurrent chemoradiotherapy followed by immunotherapy consolidation. During this treatment, thymosin alpha-1 was administered at 4.8mg each time.
干预措施: definitive radiotherapy (Radiation)
Concurrent Tα-1 group
In this concurrent Tα-1 group, participants receive concurrent chemoradiotherapy followed by immunotherapy consolidation. During this treatment, thymosin alpha-1 was administered at 4.8mg each time.
干预措施: induction chemo-immunotherapy (Drug)
Concurrent Tα-1 group
In this concurrent Tα-1 group, participants receive concurrent chemoradiotherapy followed by immunotherapy consolidation. During this treatment, thymosin alpha-1 was administered at 4.8mg each time.
干预措施: Thymosin Alpha1 (Drug)
结局指标
主要结局
Completion rate of immunotherapy
时间窗: Calculated from the start of treatment to one year after the last treatment completion
Proportion of participants completing 12 months of consolidation of immutherapy
次要结局
- Progression-free survival(one year)
- The absolute count of total lymphocyte in peripheral blood(Calculated from the start of treatment to one year after the last treatment completion; up to 18 months)
- Drop-out rate during the I/O consolidation(One year)
- Overall survival(2 years)
- The expression of peripheral blood cytokines (including IL2, IL4, IL6, IL10, TNF-α, and IFN-γ)(Calculated from the start of treatment to one year after the last treatment completion; up to 18 months)
- Incidence of ≥grade 2 pneumonia(through study completion, an average of 1 year)
- The absolute count of peripheral blood lymphocyte subsets (including CD3+, CD3+CD4+, CD3+CD8+, CD19+, CD3-CD16+CD56+, and CD56+ NK cells, PD-1+CD8+ T cells, Tim3+ CD8+ T cells, CD62lowCD4+ T cells, PD-1+CD4+ T cells, and Tim3+CD4+ T cells(Calculated from the start of treatment to one year after the last treatment completion; up to 18 months)
研究者
Hui Liu
Professor
Sun Yat-sen University