Neoadjuvant Treatment Real-world Clinical Outcomes in NSCLC: A Retrospective Multi-center Study (NeoR-World)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,500
- 试验地点
- 1
- 主要终点
- Pathological Complete Response (pCR)
研究概览
简要总结
Despite the clinical success of immune checkpoint blockade (ICB), in neoadjuvant setting, there is still a lack of valid data for operable NSCLC in the real world. This study aim to compare the clinical outcomes (pathologic response rate versus survival) of neoadjuvant immunochemotherapy with neoadjuvant chemotherapy in the real world, to explore the impact of clinicopathological factors on clinical outcomes in neoadjuvant immunochemotherapy setting, and to identify potential neoadjuvant immunochemotherapy beneficiaries.
详细描述
Although the application of neoadjuvant immunotherapy in NSCLC has brought a new treatment option to many patients, most evidence is based on interventional clinical trials, in which the participants are highly selected and the therapeutic strategies are restricted, resulting in limited representation. There is still a lack of large-scale multicenter real-world data to further verify the benefits in long term overall survival, identify the potential beneficiaries and optimize the therapeutic strategies of neoadjuvant immunochemotherapy.
To meet the forementioned need, the investigators will perform a multi-center retrospective cohort to describe the patterns of neoadjuvant immunochemotherapy use in real world, compare the efficacy of neoadjuvant immunochemotherapy ,and evaluate prognosis of neoadjuvant immunochemotherapy.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Cytological or histological diagnosis of non-small cell lung cancer
- •Patients who have previously undergone neoadjuvant immune checkpoint inhibitors and/or chemotherapy and then undergone radical surgery;
- •Stage I-III non-small cell lung cancer (IASLC/UICC staging eighth edition);
- •No previous history of malignant tumors and other malignant tumors at the same time, without any anti-tumor treatment;
- •ECOG score 0-1, heart, lung, liver, brain and kidney function can tolerate surgery;
- •At least one measurable lesion (RECIST v1.1);
- •Age >= 18 years old and <= 85 years old;
- •Be able to abide by the visits and related procedures stipulated in the program.
排除标准
- •Patients included in anti-tumor drug intervention or unblinded clinical trials, in which the treatment being administered is unknown.
- •Prior surgery, radiotherapy or systemic therapy for NSCLC, including radiofrequency ablation, etc.
研究组 & 干预措施
Resectable stage I-III NSCLC
Patients with NSCLC patients receiving neoadjuvant therapy and undergoing surgeries. Resectability after neoadjuvant therapy is judged by the multidisciplinary team of thoracic surgeon, oncologist and radiation oncologist.
干预措施: Neoadjuvant immunochemotherapy (Drug)
Resectable stage I-III NSCLC
Patients with NSCLC patients receiving neoadjuvant therapy and undergoing surgeries. Resectability after neoadjuvant therapy is judged by the multidisciplinary team of thoracic surgeon, oncologist and radiation oncologist.
干预措施: Neoadjuvant chemotherapy (Drug)
结局指标
主要结局
Pathological Complete Response (pCR)
时间窗: Within 2 weeks after surgery
defined as 0% of viable tumor cells in primary tumor and lymph nodes
Disease-free survival(DFS)
时间窗: DFS was defined as the time from surgery to the appearance of metastasis, up to approximately 5 years.
Defined as the time from the date of randomization until the date of disease recurrence or death (by any cause in the absence of recurrence).
次要结局
- Overall Survival (overall survival) Rate(From date of surgery until date of death due to any cause. Assessed at 5 years.)
- Major Pathological Response (MPR)(Within 2 weeks after surgery)
- OS (overall survival)(From date of surgery until date of death due to any cause, up to approximately 5 years.)
- EFS (event-free survival)(Up to 5 years after first therapy.)
- Event Free Survival (event-free survival) Rate(From date of first received neoadjuvant therapy to 5 years after neoadjuvant.)
- Patterns of Relapse(Within 5 years after surgery)