The Impact of Downstaging on Robotic Surgical Outcomes After Neoadjuvant Chemo-Immunotherapy in Non-Small Cell Lung Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 10
- 主要终点
- Complete resection (R0 resection)
研究概览
简要总结
The goal of this observational study is to learn whether tumor and nodal downstaging after neoadjuvant chemo-immunotherapy is associated with better surgical outcomes in patients with clinical stage IIB-III non-small cell lung cancer (NSCLC) undergoing robotic-assisted thoracic surgery. The main question it aims to answer is:
Is downstaging after neoadjuvant chemo-immunotherapy associated with better surgical outcomes in patients with stage IIB-III NSCLC undergoing robotic-assisted surgery?
Participants with resectable or potentially resectable stage IIB-III NSCLC who receive neoadjuvant chemo-immunotherapy as part of their routine clinical care and then undergo curative-intent robotic-assisted surgery will be prospectively enrolled from international centers. Clinical, operative, pathological, and postoperative outcome data will be collected, including R0 resection, the extent of resection, conversion to open surgery, postoperative complications, length of stay, readmission, and mortality.
详细描述
Please check all details of this study in Clinicaltrials.gov
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years
- •Histologically confirmed NSCLC
- •AJCC 9th clinical stage IIB-III, M0, deemed resectable or potentially resectable by the multidisciplinary tumour discussion (MDT)
- •Planned neoadjuvant chemo-immunotherapy (PD-1/PD-L1 inhibitor + platinum doublet; additional neoadjuvant RT is allowed) with curative-intent surgery
- •Received ≥1 cycle of chemo-IO (capture the intended 2-4 cycles)
- •Baseline chest CT±PET-CT within 6 weeks before starting neoadjuvant therapy
- •Restaging 2-6 weeks after last neoadjuvant dose with chest CT±PET-CT
- •Curative-intent resection planned; surgery performed 2-10 weeks after last dose
- •Performing systematic nodal dissection
- •ECOG performance status 0-
- •Complete 90-day postoperative follow-up
- •Ability to provide informed consent
排除标准
- •Metastatic disease (M1) at baseline or on restaging
- •No immunotherapy component in the neoadjuvant regimen (unless enrolled in a prespecified comparator cohort; otherwise exclude from primary analysis)
- •Prior systemic therapy or thoracic radiotherapy for the current lung cancer before starting neoadjuvant chemo-IO
- •Planned neoadjuvant chemoradiation (exclude unless including immunotherapy)
- •Definitive decision against surgery before starting neoadjuvant therapy
- •Active autoimmune disease requiring systemic immunosuppression within 2 years, prior organ transplant, or history of grade ≥2 pneumonitis/ILD
- •Uncontrolled infection, pregnancy/lactation, or any condition precluding curative-intent resection per MDT
研究组 & 干预措施
ⅡB-Ⅲ NSCLC following Neo-Chemo-IO & RATS
Patients who are undergoing robotic-assisted thoracoscopic surgery for clinical stage ⅡB-Ⅲ non-small cell lung cancer following neoadjuvant chemoimmunotherapy
干预措施: Robotic-assisted surgery (RATS) (Procedure)
结局指标
主要结局
Complete resection (R0 resection)
时间窗: From enrollment to the end of surgical treatment at 4 weeks
R0 resection (complete resection) was defined according to the International Association for the Study of Lung Cancer (IASLC) criteria as: (1) microscopically negative resection margins; (2) systematic nodal dissection including at least 6 lymph node stations (3 N1 and 3 N2, including station 7); (3) no extracapsular nodal extension; and (4) the highest mediastinal lymph node removed being negative.
次要结局
- Length of stay (LOS)(From enrollment to the end of the whole treatment in the index hospitalization)
- Major postoperative complications(From enrollment to the end of the whole treatment at 3 months)
- Conversion to open(From enrollment to the end of surgical treatment)
- Extended procedures(From enrollment to the end of surgical treatment)
- 30- and 90-day readmission rates(From enrollment to the end of treatment at 3 months)
- 30- and 90-day mortality(From enrollment to the end of treatment at 3 months)
研究者
Zhigang Li
Professor, MD, PhD
Shanghai Chest Hospital