Anti-PD-1 Antibody Sintilimab Combined With Anti-angeogensis Inhibitor Anlotinib in Treatment of Extensive-stage Disease Small Cell Lung Cancer After Failure of First Line Standard Therapy : a Single-arm Prospective Phase II Clinical Study
试验速览
- 阶段
- 2 期
- 入组人数
- 23
- 主要终点
- ORR
研究概览
简要总结
This is a the researchers launched, single-center, prospective, open-label, single arm ,Phase II clinical study of Sintilimab combined with anlotinib in patients with extensive-stage disease small-cell lung cancer to evaluate the efficacy and safety.
23 patients are expected to be enrolled in this study.
详细描述
Subjects will receive sintilimab 200mg, IV, Q3W and anlotinib 12mg, PO, QD，d1-14, Q3W treatment until disease progression, unacceptable toxicity, or death.
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
- •Aged ≥ 18, regardless of gender .
- •Histologically or cytologically confirmed small cell lung cancer .
- •The time after the end of first-line treatment was less than 6 months .
- •Subjects must have measurable diseases as defined in RECIST v1.1 .
- •Eastern Cooperative Oncology Group (ECOG) performance status scores are 0-2 .
- •Adequate hematologic and end organ function .
- •Capable of understanding the trial nature and voluntarily signing the written informed consent form .
排除标准
- •Radiographic findings showed that the tumor involved large blood vessels or was poorly demarcated from them .
- •Radiographic findings showed significant pulmonary cavitation or necrotizing tumor .
- •Active brain metastasis or meningeal metastasis .
- •With other malignant tumors in the past 5 years, except cancers that have been cured significantly or can be focally cured, e.g. basosquamous carcinoma of skin, or carcinoma cervix in situ .
- •With Interstitial lung disease, including drug- induced Interstitial lung disease or radiation pneumonitis .
- •With clinically significant cardiovascular disorder .
- •Prior exposure to any immune checkpoint inhibitors, including but not limited to other anti-CTLA-4, anti-PD-1 or anti-PD-L1 antibodies .
- •Prior exposure to anti-VEGFR therapy .
- •Known hypersensitivity to study drug or any of its excipients .
- •Treatment with any other investigational agent or participation in another clinical trial within 4 weeks prior to first administration .
- •Other conditions that the investigator thinks unsuitable in this study .
研究组 & 干预措施
Sintilimab + Anlotinib
sintilimab 200mg, IV, d1, Q3W and anlotinib 12mg, PO, QD，d1-14, Q3W; treatment until disease progression, unacceptable toxicity, or death
干预措施: Sintilimab (Drug)
Sintilimab + Anlotinib
sintilimab 200mg, IV, d1, Q3W and anlotinib 12mg, PO, QD，d1-14, Q3W; treatment until disease progression, unacceptable toxicity, or death
干预措施: Anlotinib hydrochloride (Drug)
结局指标
主要结局
ORR
时间窗: 12 month
Objective response rate according to RECIST v1.1
次要结局
- DCR(12 months)
- DoR(12 months)
- OS(on average of 2 years)
- PFS(12 months)
- Adverse Event(12 months)