Tislelizumab Plus Chemotherapy and Concurrent Thoracic Radiotherapy as First-line Therapy for Extensive-stage Small-Cell Lung Cancer (ES-SCLC): an Multicenter, Single Arm Prospective Trial
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 6
- 主要终点
- Progression-free Survival (PFS)
研究概览
简要总结
This study is a single arm, open, multicenter phase II study. The main purpose of this study was to evaluate preliminary efficacy and safety of Tislelizumab combined with thoracic radiotherapy as first line therapy for Extensive stage small cell lung cancer.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged between 18 to 80 years old (inclusive of 18th and 80th birthdays), male or female, at the time of signing the informed consent form;
- •Confirmed small cell lung cancer of extensive stage by histology or cytology;
- •At least one measurable lesion by imaging studies (according to RECIST 1.1) with a long diameter of ≥10 mm as examined by spiral CT or MRI;
- •Within 3 days prior to treatment, an ECOG score of 0 to 1;
- •No prior antitumor treatment for extensive stage disease (if the patient has previously received chemotherapy and/or radiotherapy in the limited stage of SCLC, the treatment intent must have been curative, and there must be at least a 6-month treatment-free interval between the end of chemotherapy, radiotherapy, or chemoradiotherapy and the diagnosis of extensive stage SCLC);
- •Expected life span of ≥3 months;
- •Good function of vital organs;
- •The subject voluntarily joins this study, signs the informed consent form, has good compliance, and cooperates with follow-up.
排除标准
- •Concurrent severe respiratory diseases: such as pulmonary fibrosis;
- •Presence of psychiatric disorders, hematologic diseases, autoimmune diseases, and severe primary diseases of the heart, brain, liver, or kidneys;
- •Uncontrolled active infections;
- •Known or suspected allergies to the study medication and its excipients;
- •Female patients who are pregnant or breastfeeding, or women of childbearing potential with a positive baseline pregnancy test;
- •Prior use of antitumor treatment targeting the PD-(L)1 pathway.
研究组 & 干预措施
ICI+EC/EP+TRT
Drug: Tislelizumab Drug: Carboplatin Drug: Etoposide Radiation: Radiation therapy Drug: Cisplatin
干预措施: Thoracic radiotherapy (Radiation)
ICI+EC/EP+TRT
Drug: Tislelizumab Drug: Carboplatin Drug: Etoposide Radiation: Radiation therapy Drug: Cisplatin
干预措施: Carboplatin or Cisplatin (Drug)
ICI+EC/EP+TRT
Drug: Tislelizumab Drug: Carboplatin Drug: Etoposide Radiation: Radiation therapy Drug: Cisplatin
干预措施: Tislelizumab (Drug)
ICI+EC/EP+TRT
Drug: Tislelizumab Drug: Carboplatin Drug: Etoposide Radiation: Radiation therapy Drug: Cisplatin
干预措施: Etoposide (Drug)
结局指标
主要结局
Progression-free Survival (PFS)
时间窗: Up to 2 years
From the date of enrollment to the date of disease progression
次要结局
- Overall Survival （OS）(Up to 2 years)
- Objective Response Rate (ORR)(Up to 2 years)
- Adverse events(Up to 2 years)
- Disease Control Rate (DCR)(Up to 2 years)
研究者
Gang Jin
Dr.
Second Hospital of Shanxi Medical University