Dynamic Monitoring of MRD in Neoadjuvant Chemoimmunotherapy for Resectable Stage II-IIIB Non-small Cell Lung Cancer：An Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Event free survival(EFS)
研究概览
简要总结
Predicting relapse and overall survival in potentially resectable Stage IIIA-IIIB Non-small Cell Lung Cancer (NSCLC) patients remains challenging. It is now widely recognized that patients with detectable MRD have a worse prognosis than those with undetectable MRD. Therefore, investigators performed this prospective clinical trial to evaluate the predictive value of MRD with increased risk of relapse and improves prediction of outcome in potentially resectable Stage IIIA-IIIB NSCLC with neoadjuvant chemoimmunotherapy. In this study, investigators will pay more attention to the long-term follow-up time and dynamic monitoring of MRD. The predictive value of MRD with Disease-free survival (DFS) rate was observed as the primary endpoint. Besides that, the correlation of MRD with major pathologic response (MPR) rate, pathologic complete response (pCR) rate，event-free survival(EFS) rate and overall survival (OS) were observed as the second endpoints. Investigators hope it will provide a new insight for these potentially resectable Stage IIA-IIIB NSCLC with neoadjuvant chemoimmunotherapy.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or
- •Have previously untreated and histological examination confirms resectable stage II-IIIA/IIIB non-small cell lung cancer (according to the 8th edition of the AJCC TNM staging criteria), and the pathological type of squamous cell carcinoma and non-squamous cell carcinoma needs to be distinguished, and EGFR, ALK, and ROS1 should be negative for non-squamous non-small cell lung cancer
- •Adequate organ function and expected survival time ≥ 12 weeks;
- •Evidence of post-menopausal status or negative urinary or serum pregnancy test for female pre-menopausal patients.
排除标准
- •Presence of mixed carcinoma component on histology.
- •Patients with other active malignancies within 5 years prior to enrollment.
- •Known active autoimmune diseases.
- •Currently participate in an interventional clinical study treatment or have been treated with another drug or investigational device within 4 weeks prior to the first dose.
- •Use of immunosuppressive agents within 14 days prior to the first dose of study treatment.
- •Presence of other uncontrolled serious medical conditions.
研究组 & 干预措施
immunotherapy and chemotherapy
Participants received two to three cycles of neoadjuvant chemoimmunotherapy before surgery. Adjuvant chemotherapy was also administered for 2-3 cycles after surgery. In addition, MRD was detected within 30 days before surgery, 1 week after surgery, 1 month ±7days after surgery, 6 months after surgery.
干预措施: Sintilimab plus chemotherapy (Drug)
结局指标
主要结局
Event free survival(EFS)
时间窗: Six months after the surgery
Defined as the time from randomization to the occurrence of any event, including disease progression, discontinuation of treatment for any reason, or death
次要结局
- Overall Survival (OS)(Six months after the surgery)
- Disease-Control Rate (DCR)(Six months after the surgery)
- Major pathological response rate (MPR)(At the end of 2-3 cycles of neoadjuvant therapy (each cycle is 21 days))
- Objective Response Rate (ORR)(Six months after the surgery)
- Pathological complete response rate（PCR）(At the end of 2-3 cycles of neoadjuvant therapy (each cycle is 21 days))