NCT05882630尚未招募1 期
Surufatinib Combined With Serplulimab Plus Carboplatin and Etoposide as First-line Treatment for Extensive-stage Small-cell Lung Cancer：a Multicenter, Open-label, Phase I/II Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 39
- 试验地点
- 1
- 主要终点
- Progress Free Survival(PFS)
研究概览
简要总结
To evaluates the effectiveness and safety of Surufatinib combined with Serplulimab plus chemotherapy for the first-line treatment of ES-SCLC, and maintenance therapy are Surufatinib combined with Serplulimab
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must have the ability to understand and voluntarily sign informed consent;
- •Age: 18-75 years old;
- •Expected survival period ≥ 3 months;
- •Histologically or cytologically diagnosed with ES-SCLC (Combined small cell lung carcinoma excepted);
- •No prior systemic therapy for ES-SCLC;
- •According to the RECIST 1.1 standard, the patient has at least one target lesion with a measurable diameter;
- •ECOG PS: 0-1;
- •Major organs are functioning well;
- •The urine or serum pregnancy test results of premenopausal women were negative.
排除标准
- •Patients with symptomatic brain metastases;
- •People with hypertension who cannot be well controlled by double antihypertensive drug (systolic blood pressure≥140 mmHg, diastolic blood pressure≥90 mmHg);
- •Urine routine test showed urine protein ≥++ and confirmed 24-hour urine protein quantification>1.0g;
- •Cardiovascular disease history: congestive heart failure> New York Heart Association (NYHA) standard II, patients with active coronary artery disease (those with myocardial infarction 6 months before enrollment can be enrolled), arrhythmia requiring treatment;
- •Active severe clinical infections (>NCI-CTCAE 5.0 version 2 infection criteria), including tuberculosis (clinical evaluation, including clinical history, physical examination, imaging findings and TB examination in line with local clinical practice), hepatitis B (known HBV Surface antigen [HbsAg] positive), hepatitis C or human immunodeficiency virus (HIV 1/2 antibody positive);Patients who have previously had HBV infection or have been cured (defined as the presence of hepatitis B core IgG antibodies and the absence of HBsAg) are eligible. Hepatitis C virus (HCV) antibody-positive patients are only eligible if the HCV RNA polymerase chain reaction is negative.
- •Patients with bleeding tendency or coagulation disorders;
- •In the past 2 years, there are active autoimmune diseases that require systemic treatment (such as corticosteroids or immunosuppressive drugs), and related alternative treatments (such as thyroxine, insulin, or physiological corticosteroid replacement for renal or pituitary insufficiency) are allowed treatment);
- •Patients who are pregnant or breastfeeding;
- •Allergy to any of the drugs in the study;
- •Imaging (CT or MRI) shows that the tumor invades or is poorly demarcated from large vessels;
- •Researchers think it is inappropriate to participate in this trial.
研究组 & 干预措施
Surufatinib Combined With Serplulimab and EC Chemotherapy
Experimental
干预措施: Surufatinib,Serplulimab,Etoposide,Carboplatin (Drug)
结局指标
主要结局
Progress Free Survival(PFS)
时间窗: up to 24 months
次要结局
- Disease control rate(DCR)(up to 24 months)
- Objective response rate(ORR)(up to 24 months)
- Overall Survival(OS)(up to 24 months)
研究者
研究点 (1)
Loading locations...
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