Sintilimab Combined With Anlotinib for Perioperative Non-small Cell Lung Cancer Based on MRD Evaluation: a Clinical Study
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Major pathologic response (MPR)
研究概览
简要总结
To study the efficacy of sintilimab combined with anlotinib for perioperative non-small cell lung cancer. To explore the clearance effect of sintilimab combined with anlotinib for postoperative adjuvant therapy based on evaluating minimal residual disease.
详细描述
Patients with resectable non-small cell lung cancer (NSCLC) have a high postoperative recurrence rate. Perioperative treatment, which can improve the resection rate and clear the minimal residual disease, is the main mean of preventing recurrence, including preoperative neoadjuvant and postoperative adjuvant therapies. In recent years, immunotherapy can significantly improve the pathological remission rate and prolong the survival as a perioperative treatment. In addition to single-agent or combined chemotherapy, the exploration of immunotherapy with other therapeutic strategies is still lacking.
In 2018, we originally designed sintilimab combined with anlotinib in the first-line treatment of advanced NSCLC.
This clinical study plans to: ① apply the "de-chemotherapy" model to the perioperative phase of early NSCLC, ② explore sintilimab combined with anlotinib in preoperative neoadjuvant and postoperative adjuvant therapies, ③ explore clearance effect of sintilimab combined with anlotinib for postoperative adjuvant therapy based on evaluating minimal residual disease (MRD), in order to improve the efficacy of perioperative NSCLC and prolong survival.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Histologically or cyologically confirmed stage II-IIIa NSCLC patients;
- •NSCLC patients with negative driver gene: EGFR wild-type, no ALK fusion mutation, no ROS1 fusion mutation;
- •ECOG PS: 0~1;
- •Pulmonary function index meets the surgical criteria;
- •No previous systemic anti-tumor treatment.
排除标准
- •Patients with central cavitary squamous cell carcinoma or investigator-assessed bleeding symptoms or bleeding tendency were excluded.
研究组 & 干预措施
Combination therapy group
Sintilimab combined with anlotinib
干预措施: sintilimab combined with anlotinib (Drug)
Single-agent therapy group
Sintilimab monotherapy
干预措施: sintilimab monotherapy (Drug)
结局指标
主要结局
Major pathologic response (MPR)
时间窗: 2 months
Residual tumor cells of the surgical specimens were ≤10% based on pathological evaluation.
次要结局
- Overall survival (OS)(32 months)
- Event free survival (EFS)(16 months)
- Complete pathologic response (CPR)(2 months)
研究者
Tianqing Chu
Associate Chief Physician
Shanghai Chest Hospital