An Open, Single Arm, Single Center Phase Ib Clinical Trial to Evaluate the Efficacy and Safety of TQB2450 Combined With Anlotinib as Maintenance Therapy in Patients With Limited Stage Small Cell Lung Cancer Without Progression After First-line Radiotherapy and Chemotherapy
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- serious adverse event
研究概览
简要总结
To assess the efficacy and safety of TQB2450 in combination with anlotinib as maintenance therapy in patients with limited-stage small cell lung cancer who do not progress after first-line chemoradiotherapy. Based on the incidence and severity of benign and serious adverse events, as well as abnormal laboratory
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
- •The subject voluntarily joins the study, signs the informed consent form, and has good compliance;
- •Age: 18~75 years old (when signing the informed consent form); ECOG PS score: 0-1 points; Expected survival beyond 6 months; body weight> 40 kg;
- •Patients with pathologically confirmed limited-stage small cell lung cancer (according to the Veterans Administration Lung Study Group (VALG stage);
- •Through the neck, chest, abdomen, pelvic enhanced CT and brain plain scan + enhanced MRI examination with diagnostic quality, there is no evidence of metastatic disease (PET-CT examination is recommended before starting radiotherapy and chemotherapy, if not performed before radiotherapy and chemotherapy PET-CT examination, bone scan examination should be performed; PET-CT examination must be performed during the screening period after chemoradiotherapy to exclude metastasis);
- •It is expected that no tumor resection will be required during the study (patients who are not suitable for surgery or those who are unwilling to undergo surgery are acceptable);
- •Radiotherapy technology adopts three-dimensional conformal radiotherapy, conformal intensity-modulated radiotherapy, tomographic radiation therapy and other precision radiotherapy technologies;
- •Patients must achieve CR, PR or SD after receiving radical platinum-based CRT and cannot develop disease progression;
- •Patients with at least one measurable lesion confirmed according to RECIST 1.1 criteria prior to chemoradiotherapy;
排除标准
- •Complex small cell lung cancer confirmed by histopathology or cytopathology;
- •Subjects with known central nervous system metastasis and/or cancerous meningitis;
- •Malignant pleural effusion and pericardial effusion;
- •Imaging shows that the tumor has invaded important blood vessels, or the researcher has determined that the tumor is highly likely to invade important blood vessels and cause fatal massive bleeding during subsequent studies;
- •Within 2 weeks before the start of the study treatment, he has received the treatment of traditional Chinese patent medicines and simple preparations with anti-tumor indications specified in the NMPA approved drug manual;
- •Patients who have received immunomodulatory drugs within 30 days before starting treatment;
- •Previously received anti PD-1, anti PD-L1, or anti PD-L2 drugs or medication targeting another stimulating or co inhibitory T cell receptor;
- •Previous use of antivascular survival drugs（ bevacizumab, arotinib, apatinib ,ect);
研究组 & 干预措施
TQB2450 Injection + Anlotinib Hydrochloride Capsules
TQB2450 injection: 1200 mg/time, intravenous drip, day 1, Q3W; Anlotinib Hydrochloride Capsules: 8 mg/dose, once daily (QD), continuously used for 2 weeks, stopped for 1 week, and taken orally before breakfast (the starting dose of Anlotinib Hydrochloride is 8 mg, and it is allowed to be increased to 10 mg after two cycles of use)
干预措施: TQB2450 Injection + Anlotinib Hydrochloride Capsules (Drug)
结局指标
主要结局
serious adverse event
时间窗: Start from the first dose until the last dose to within 84 days after the last dose or start new target indication treatment (whichever occurs first)
Incidence and Severity of Serious Adverse Events
Adverse event
时间窗: Start from the first dose until the last dose to within 84 days after the last dose or start new target indication treatment (whichever occurs first)
Incidence and severity of adverse events
次要结局
- Overall response rate (ORR)(Up to approximately 36 months)
- disease control rate(Up to approximately 36 months)
- duration of remission(Up to approximately 36 months)
研究者
Jinming Yu
Principal investigator
Shandong Cancer Hospital and Institute