A Prospective, Multicenter, Randomized Controlled, Phase II Study of Probiotics Combined With Concurrent Hyperfractionated ChemoRadiotherapy and Adebrelimab Immunomaintenance in the Treatment of Limited-stage Small Cell Lung Cancer (LS-SCLC)
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- one year progression free survival rate
研究概览
简要总结
ADRIATIC study explored the benefits of immune maintenance therapy after LS-SCLC radiotherapy and chemotherapy. In the presence of immunotherapy, is it necessary to increase the dosage of radiotherapy and can it further improve the efficacy? This study aims to explore the efficacy and safety of simultaneous integrated boost hyperfractionation radiotherapy combined with probiotics and Adalberg monoclonal antibody consolidation therapy for small cell lung cancer.
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
- Single (Investigator)
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
- •Sign written informed consent before implementing any experimental procedures;
- •Age range: 18-80 years old;
- •Pathological diagnosis of small cell lung cancer;
- •Limited stage;
- •ECOG PS 0-1；
- •Receive ≤ 2 rounds of chemotherapy or chemotherapy plus immunotherapy;
- •Expected survival time>3 months;
排除标准
- •Progress after 2 induction treatments;
- •Severe emphysema, interstitial changes in the lungs, COPD patients;
- •Resting blood oxygen<93;
- •Have a history of other malignant tumors and have received chemotherapy in the past 3 years;
- •History of chest radiotherapy;
研究组 & 干预措施
Probiotics Combined with Concurrent Hyperfractionated Radiotherapy and Adebrelimab Immunomaintenance
Chest radiotherapy (PTV-G: 54Gy/30F, bid; PTV-C: 45Gy/30F, bid) started before the fourth etoposide and cisplatin chemotherapy, and the subjects will be given probiotics before radiotherapy. Adebrelimab (1200mg) was given in the first week after radiotherapy, and mantained every 3 weeks for 2 year.
干预措施: Immunotherapy (Drug)
Concurrent Hyperfractionated Radiotherapy and Adebrelimab Immunomaintenance
Chest radiotherapy (PTV-G: 54Gy/30F, bid; PTV-C: 45Gy/30F, bid) started before the fourth etoposide and cisplatin chemotherapy. Adebrelimab (1200mg) was given in the first week after radiotherapy, and mantained every 3 weeks for 2 year.
干预措施: Immunotherapy (Drug)
Probiotics Combined with Concurrent Hyperfractionated Radiotherapy and Adebrelimab Immunomaintenance
Chest radiotherapy (PTV-G: 54Gy/30F, bid; PTV-C: 45Gy/30F, bid) started before the fourth etoposide and cisplatin chemotherapy, and the subjects will be given probiotics before radiotherapy. Adebrelimab (1200mg) was given in the first week after radiotherapy, and mantained every 3 weeks for 2 year.
干预措施: Probiotics (Drug)
Probiotics Combined with Concurrent Hyperfractionated Radiotherapy and Adebrelimab Immunomaintenance
Chest radiotherapy (PTV-G: 54Gy/30F, bid; PTV-C: 45Gy/30F, bid) started before the fourth etoposide and cisplatin chemotherapy, and the subjects will be given probiotics before radiotherapy. Adebrelimab (1200mg) was given in the first week after radiotherapy, and mantained every 3 weeks for 2 year.
干预措施: concurrent Hyperfractionated Radiotherapy (Radiation)
Concurrent Hyperfractionated Radiotherapy and Adebrelimab Immunomaintenance
Chest radiotherapy (PTV-G: 54Gy/30F, bid; PTV-C: 45Gy/30F, bid) started before the fourth etoposide and cisplatin chemotherapy. Adebrelimab (1200mg) was given in the first week after radiotherapy, and mantained every 3 weeks for 2 year.
干预措施: concurrent Hyperfractionated Radiotherapy (Radiation)
结局指标
主要结局
one year progression free survival rate
时间窗: one year
Complete response rate at the end of radiotherapy for one month
时间窗: at the end of radiotherapy for one month
次要结局
- Adverse reactions(one year)
- one year Survival rate without distant metastasis(one year)
- One year overall survival rate(one year)
研究者
Xingwen Fan
associate professor
Fudan University