NCT07815223招募中2 期
A Prospective, Single-Arm, Phase II Study of Tislelizumab Plus Anlotinib as Consolidation Therapy in Patients With Limited-Stage Small Cell Lung Cancer Without Progression After Concurrent or Sequential Chemoradiotherapy
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Progression Free Survival (PFS)
研究概览
简要总结
This prospective, single-arm, phase II study aims to evaluate the efficacy and safety of tislelizumab plus anlotinib as consolidation therapy in patients with limited-stage small cell lung cancer (LS-SCLC) who have not progressed following concurrent or sequential chemoradiotherapy.
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
- •Provide written informed consent and be willing and able to comply with study requirements and scheduled assessments;
- •Be aged 18-75 years at the time of consent;
- •Have an ECOG performance status of 0 or 1;
- •Have histologically or cytologically confirmed small-cell lung cancer;
- •Have radiologically confirmed limited-stage disease;
- •Have achieved a complete response, partial response, or stable disease after concurrent or sequential chemoradiotherapy, according to RECIST version 1.1;
- •Have a life expectancy of at least 3 months;
- •Have adequate organ function.
排除标准
- •Received systemic immunostimulatory agents, including interferons, interleukin 2, or tumour necrosis factor, within 4 weeks or five half-lives before the first dose of study treatment, whichever is longer; previous cancer vaccines are permitted;
- •Received any traditional Chinese herbal medicine for cancer control within 14 days before the first dose;
- •Required systemic corticosteroids equivalent to more than 10 mg per day of prednisone or other immunosuppressive treatment within 14 days before the first dose;
- •Received a live vaccine within 4 weeks before the first dose; inactivated seasonal influenza vaccines are permitted, but live intranasal influenza vaccines are not;
- •Underwent major surgery requiring general anaesthesia within 28 days before the first dose;
- •Had previous allogeneic stem-cell or organ transplantation;
- •Have clinically significant pericardial effusion;
- •Have uncontrolled pleural effusion or ascites requiring drainage within 2 weeks before enrolment;
- •Have active autoimmune disease or a history of autoimmune disease with a risk of recurrence;
- •Have a history of interstitial lung disease or non-infectious pneumonitis, or uncontrolled systemic disease, including diabetes, hypertension, pulmonary fibrosis, or acute lung disease;
- •Have a severe chronic or active infection requiring systemic antibacterial, antifungal, or antiviral treatment within 2 weeks before the first dose, including tuberculosis;
- •Have had another active malignancy within 2 years before the first dose, except the cancer under investigation or definitively treated localised cancers, including resected basal-cell or squamous-cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix or breast;
- •Have untreated chronic hepatitis B, chronic HBV infection with an HBV DNA concentration of at least 500 IU/mL (2500 copies/mL), or active hepatitis C;
- •Have a known history of HIV infection;
- •Have clinically significant cardiovascular risk factors;
- •Have unresolved toxicities from previous anticancer treatment that have not returned to baseline or stabilised, except adverse events unlikely to pose a safety risk, such as alopecia, neuropathy, or specified laboratory abnormalities;
- •Have a history of severe hypersensitivity to monoclonal antibodies.
研究组 & 干预措施
Tislelizumab + Anlotinib
Experimental
干预措施: Tislelizumab + Anlotinib (Drug)
结局指标
主要结局
Progression Free Survival (PFS)
时间窗: Up to 36 months
Overall Survival (OS)
时间窗: Up to 48 months
次要结局
- 6- and 12-month progression-free survival rates(Up to 36 months)
- Objective Response Rate (ORR)(Up to 36 months)
- Disease Control Rate (DCR)(Up to 36 months)
- Duration of Response (DoR)(Up to 36 months)
- Adverse Events (AEs)(Up to 36 months)
研究者
研究点 (1)
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