Rh-Endostatin Combined With Low-dose CCRT(50 Gy) Followed by Durvalumab Maintenance for the Treatment of Specific Phase III NSCLC Who Can Not Tolerate 60 Gy Irradiation
试验速览
- 阶段
- 4 期
- 入组人数
- 97
- 主要终点
- adverse events (AE)
研究概览
简要总结
A Study to Assess the Effects of Durvalumab following Rh-Endostatin combined with reduced-dose CCRT(50 Gy) in Patients with Stage III Unresectable Non-Small Cell Lung Cancer who can not tolerate 60 Gy irradiation.
详细描述
A Phase II, Single-arm, Multi-centre Study of Durvalumab as Sequential Therapy in Patients with Locally Advanced, Unresectable Non-Small Cell Lung Cancer (Stage III) Who Have Not Progressed Following Rh-Endostatin combined with reduced-dose CCRT(50 Gy) Therapy (Relief)
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
- •Age at 18-75 years.
- •Documented evidence of NSCLC (locally advanced, unresectable, Stage III)
- •Measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST)
- •Eastern Cooperative Oncology Group performance status score (ECOG PS) of 0 to
- •Estimated life expectancy of more than 12 weeks.
排除标准
- •Prior exposure to any anti-PD-1 or anti-PD-L1 antibody.
- •Active or prior autoimmune disease or history of immunodeficiency.
- •Evidence of severe or uncontrolled systemic diseases, including active bleeding diatheses or active infections including hepatitis B, C and HIV.
- •Evidence of uncontrolled illness such as symptomatic congestive heart failure, uncontrolled hypertension or unstable angina pectoris.
- •Any unresolved toxicity CTCAE >Grade 2 from the prior chemoradiation therapy.
- •Active or prior documented inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis).
研究组 & 干预措施
Endostar combined Radiation
干预措施: Recombinant human endostatin (Endostar) (Drug)
Endostar combined Radiation
干预措施: Thoracic irradiation of 50 Gy with 3DCRT or IMRT (Radiation)
结局指标
主要结局
adverse events (AE)
时间窗: 5 years from patient enrollment
Number of participants with adverse events as assessed by CTCAE v5.0
Progression Free Survival
时间窗: up to approximately 3 years
PFS was defined as the time from randomization until the date of objective disease progression (RECIST 1.1) or death (by any cause in the absence of progression).
次要结局
- Objective Response Rate(Tumor scans performed at baseline then every ~8 weeks up to 48 weeks, then every ~ 12 weeks thereafter up to 3 three years)
- Overall Survival(up to 5 years from patient enrollment)
研究者
Xuwei Cai
Deputy Chief Physician
Shanghai Chest Hospital