Chemoradiotherapy With or Without Sintilimab in Limited-stage Small Cell Lung Cancer: a Multicenter Prospective Randomized Phase II Trial
试验速览
- 阶段
- 2 期
- 入组人数
- 140
- 主要终点
- Progression-free survival
研究概览
简要总结
The study is a prospective, multi-center, open-label, randomized, and controlled phase II clinical trial.
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/cytologically confirmed diagnosis of SCLC.
- •Radiologically (including brain CT/MRI, chest and abdomen contrasted CT and bone scintigraphy. PET/CT is recommended) confirmed limited-stage.
- •Patients should be ≥ 18 years old.
- •ECOG performance status of 0-1 (Karnofsky performance status ≥ 80).
- •With adequate cardiac, pulmonary, bone marrow, hepatic and renal function.
- •With weight loss no more than 10% within 6 months before diagnosis.
- •Informed consent must be signed.
排除标准
- •Histology confirmed the mixed NSCLC components;
- •Other primary malignant tumors appeared within 5 years before the first administration of the study drug, except for locally curable malignant tumors after radical treatment (such as basal or squamous cell skin cancer, superficial bladder cancer or prostate, cervical or breast carcinoma in situ, etc.);
- •Any disease or condition contraindicated by radiotherapy or chemotherapy;
- •Malignant pleural effusion and pericardial effusion;
- •Pregnant and lactating women;
- •History of idiopathic pulmonary fibrosis (IPF), including pneumonia and organic pneumonia;
- •Received live vaccination within 28 days before the first administration of the study drug;
- •28 days prior to the first administration of the study drug, he participated in any other drug clinical trials or is undergoing other clinical trials.
- •Have received any antibody / drug (including PD-1, PDL1, CTLA4, tim3, Lag3, etc.) targeting T-cell co regulatory protein (immunocheckpoint).
- •The investigator believes that the subject's complications or other circumstances may affect the compliance with the protocol or may not be suitable for the study.
研究组 & 干预措施
Sintilimab + CRT arm
Patients with limited-stage SCLC receive etoposide and cisplatin (carboplatin) plus Sintilimab induction therapy for 2 cycles and then receive thoracic radiotherapy (45 Gy/30 fractions) with concurrent EP/EC chemotherapy for 2cycles. Patients who achieve CR or PR then receive prophylactic cranial irradiation (PCI, 25 Gy/10 fractions). After PCI, Sintilimab maintenance therapy will be administered once every 3 week for 13 cycles.
干预措施: Sintilimab (Drug)
Sintilimab + CRT arm
Patients with limited-stage SCLC receive etoposide and cisplatin (carboplatin) plus Sintilimab induction therapy for 2 cycles and then receive thoracic radiotherapy (45 Gy/30 fractions) with concurrent EP/EC chemotherapy for 2cycles. Patients who achieve CR or PR then receive prophylactic cranial irradiation (PCI, 25 Gy/10 fractions). After PCI, Sintilimab maintenance therapy will be administered once every 3 week for 13 cycles.
干预措施: Etoposide (Drug)
Sintilimab + CRT arm
Patients with limited-stage SCLC receive etoposide and cisplatin (carboplatin) plus Sintilimab induction therapy for 2 cycles and then receive thoracic radiotherapy (45 Gy/30 fractions) with concurrent EP/EC chemotherapy for 2cycles. Patients who achieve CR or PR then receive prophylactic cranial irradiation (PCI, 25 Gy/10 fractions). After PCI, Sintilimab maintenance therapy will be administered once every 3 week for 13 cycles.
干预措施: Cisplatin (Drug)
Sintilimab + CRT arm
Patients with limited-stage SCLC receive etoposide and cisplatin (carboplatin) plus Sintilimab induction therapy for 2 cycles and then receive thoracic radiotherapy (45 Gy/30 fractions) with concurrent EP/EC chemotherapy for 2cycles. Patients who achieve CR or PR then receive prophylactic cranial irradiation (PCI, 25 Gy/10 fractions). After PCI, Sintilimab maintenance therapy will be administered once every 3 week for 13 cycles.
干预措施: radiotherapy (Radiation)
CRT arm
Patients with limited-stage SCLC receive etoposide and cisplatin (carboplatin) for 2 cycles and then receive thoracic radiotherapy (45 Gy/30 fractions) with concurrent EP/EC chemotherapy for 2cycles. Patients who achieve CR or PR then receive prophylactic cranial irradiation (PCI, 25 Gy/10 fractions).
干预措施: Etoposide (Drug)
CRT arm
Patients with limited-stage SCLC receive etoposide and cisplatin (carboplatin) for 2 cycles and then receive thoracic radiotherapy (45 Gy/30 fractions) with concurrent EP/EC chemotherapy for 2cycles. Patients who achieve CR or PR then receive prophylactic cranial irradiation (PCI, 25 Gy/10 fractions).
干预措施: Cisplatin (Drug)
CRT arm
Patients with limited-stage SCLC receive etoposide and cisplatin (carboplatin) for 2 cycles and then receive thoracic radiotherapy (45 Gy/30 fractions) with concurrent EP/EC chemotherapy for 2cycles. Patients who achieve CR or PR then receive prophylactic cranial irradiation (PCI, 25 Gy/10 fractions).
干预措施: radiotherapy (Radiation)
结局指标
主要结局
Progression-free survival
时间窗: 2 years
PFS, defined as the time from the date of randomization to the first date of documented objective progression disease or of death from any cause.
次要结局
- Overall survival(5 years)
- Overall response rates(2 years)