The Efficacy of PD-1 Antibody Sintilimab on Early-stage Multiple Primary Lung Cancer With Ground Glass Density: A Prospective Interventional Two-stage Simon Design Phase II Study.
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- ORR of target lesions.
研究概览
简要总结
A single-center,prospective interventional study to explore the efficacy of PD-1 antibody Sintilimab on early-stage multiple primary lung cancer patients with ground-glass nodules in CT scan.
详细描述
This study is a single-center,prospective interventional clinical study, all subjects enrolled are multiple primary lung cancer patients with ground-glass density in CT scan.The samples plan for the study was 36 cases.The enrolled patients will receive intravenous infusion of Sintilimab 200mg every 3 weeks up to 4 cycles, and the efficacy will be evaluated after cycle 2 and 4 using RECIST criteria (version 1.1 ).
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Two or more ground-glass lesions (pure ground glass or partially solid) presented in the CT scan of lung that cannot be operated simultaneously
- •There was at least one lung cancer lesion with a diameter of 1-3cm confirmed pathologically or by multidisciplinary team.
- •Excluding lymph nodes and distant metastasis through imaging
- •ECOG PS 0-1
- •Vital organ functions meet the following requirements: 1)The absolute count of neutrophils ≥1.5×109/L 2)Platelet ≥90×109/L 3)Hemoglobin ≥9g/dL 4)Serum albumin ≥3g/dL 5)Thyroid stimulating hormone (TSH) ≤ULN (if abnormal, T3 and T4 levels should be examined at the same time; if T3 and T4 levels are normal, they can be included in the group) 6)Bilirubin ≤ULN 7)ALT and AST≤1.5 ULN 8)AKP≤ 2.5ULN or less 9)Serum creatinine ≤1.5 ULN or creatinine clearance ≥60mL/min
- •Subjects volunteered to participate in this study and signed informed consent, with good compliance.
排除标准
- •Non-calcified lesions with diameter more than 3mm are presented
- •The presence of any active autoimmune diseases or a history of autoimmune diseases
- •Those who have used other drugs in clinical study within 4 weeks before the first time of drug use
- •Severe allergic reaction to monoclonal antibody
- •Heart clinical symptoms or diseases are not well controlled
- •Subjects with congenital or acquired immune deficiency (such as HIV infection) or active hepatitis
- •According to the researcher's judgment, the subjects have other factors that may lead to the forced termination of this study
研究组 & 干预措施
PD-1 Antibody Sintilimab
Patients receive the treatment of PD-1 antibody Sintilimab
干预措施: PD-1 antibody Sintilimab (Drug)
结局指标
主要结局
ORR of target lesions.
时间窗: 3 months
The objective response rate will be evaluated after 4 courses of treatment
次要结局
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0(3 months)
研究者
Jianxing He
professor
The First Affiliated Hospital of Guangzhou Medical University