NCT04102982Unknown2 期
Shandong Provincial Hospital Affiliated to Shandong University
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 200
- 试验地点
- 13
- 主要终点
- Objective response rate
研究概览
简要总结
Patients were randomized to microwave ablation plus camrelizumab group or camrelizumab group.
详细描述
Patients in the camrelizumab group were treated with camrelizumab with the dose of 200mg on day 1, repeated every 21 days.Patients in the combination group were treated with MWA in the primary tumor followed by camrelizumab with the dose of 200mg on day 1, repeated every 21 days.
The primary end point is overall survival. The second end points include progression free survival, objective response rate and safety.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- •Aged 18 to 75 years old
- •Cytologically or pathologically verified non-small cell lung cancer (NSCLC)
- •Patients with distant metastases or postoperative recurrence
- •EGFR or ALK sensitive mutations are negative (all patients, including non-adenocarcinoma patients)
- •At least one line of platinum-based doublet chemotherapy was administrated
- •Eastern Cancer Cooperative Group（ECOG）Performance Status（PS）of 0 to 1
- •At least two measurable tumors (in other words a measurable tumor lesion exclusive primary tumors)
- •Asymptomatic brain metastases or symptomatic brain metastases under control
- •If treated with irradiation，at least one month interval between radiation and randomization 10）Cardiopulmonary function, laboratory test indicators without ablation or chemotherapy contraindications
- •Informed conssent can be obtained 12) Sufficient tissue specimens for PD-L1 or TMB or blood samples were provided (1 week before treatment, 1 week after ablation, and once every two months for immune evaluation) for subsequent analysis
排除标准
- •Mixed lung cancer contains neuroendocrine tumor, small cell lung cancer or sarcoma
- •Suffering from other malignant tumors within five years
- •EGFR, ALK sensitive mutations are positive or unknown
- •Uncontrolled pleural effusion or pericardial effusion
- •Uncontrolled symptomatic brain metastases
- •Previously anti-PD-1, anti-PD-L1, anti-CTLA-4 or Car-T immunotherapy
- •severe interstitial pneumonia with severe diffuse dysfunction
- •Autoimmune diseases require long-term hormone therapy patients
- •Patients required consistent application of prednisone
- •Uncontrolled pulmonary infection or antibiotics stopped within 1 month
- •Acute cardiovascular and cerebrovascular diseases such as acute cerebral infarction and acute coronary syndrome within 1 month
- •Patients during pregnancy or lactation
- •Life expectance of 3 months or less
研究组 & 干预措施
Microwave ablation plus camrelizumab group
Active Comparator
Patients in the group are treated with Microwave ablation in the primary tumor, followed by camrelizumab.
干预措施: Camrelizumab plus microwave ablation (Other)
Camrelizumab group
Placebo Comparator
Patients in the group are treated with camrelizumab alone.
干预措施: Camrelizumab (Drug)
结局指标
主要结局
Objective response rate
时间窗: The proportion of Patients achieved complete response or partial response up to 16 weeks
ORR
次要结局
- Overall survival(From date of randomization until the date of first documented date of death from any cause，assessed up to 24 months)
- Progression free survival(From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months)
- Safety(The proportion and grade of patients had adverse events up to 24 months)
研究者
Xin Ye
Head of Section
Shandong Provincial Hospital
研究点 (13)
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