Safety and Feasibility of Surgery After Conversion Therapy for Locally Advanced and Advanced NSCLC
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Ruijin Hospital
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- perioperative morbidity
Study Overview
Brief Summary
Lung cancer is one of the most common malignant tumors worldwide and the mortality ranks first in the world. In recent years, with the development of targeted therapy and immunotherapy, the overall survival of lung cancer patients has improved significantly. However, the inoperable advanced tumor remains the main reason for the poor prognosis of lung cancer. Thus, we aim to carry out this single-arm, prospective study to evaluate the safety and feasibility of surgery after conversion therapy for locally advanced and advanced non-small cell lung cancer.
Detailed Description
Previous studies have shown that selective surgery after conversion therapy is feasible and safe in locally advanced or stage IV patients, and indicates potential benefits for these patients. However, surgery after conversion therapy is difficult and has high risk of postoperative complications which requires strict operation indications and patient screening. At present, there are only relevant retrospective studies and no prospective evidence. Therefore, our team plans to carry out this single-arm prospective clinical trial to evaluate the safety and feasibility of surgery in patients with locally advanced and advanced non-small cell lung cancer after conversion therapy, so as to lay the foundation for further research and clinical application.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Volunteer to participate in the study with good compliance. Able to complete the observation and follow-up and have signed the informed consent;
- •More than 18 years old with no limit of sex;
- •Pathologically confirmed stage T4N0-3 or T1-3N2-3 NSCLC with residual tumor after first-line treatment (first-line chemotherapy, targeted therapy, immunotherapy, chemotherapy combined with immunotherapy, etc.) evaluated operable for radical resection; pathologically confirmed stage IVA NSCLC evaluated operable after first-line treatment (first-line chemotherapy, targeted therapy, immunotherapy, chemotherapy combined with immunotherapy, etc.);
- •ASA score: I-III;
- •Cardiopulmonary functions meet the requirements of radical operation for lung cancer with normal liver and kidney functions.
Exclusion Criteria
- •Serious heart, lung, liver and kidney dysfunction and unable to tolerate the operation;
- •Neurologic, mental illness or mental disorder which is hard to control, poor compliance, unable to cooperate or describe the treatment response;
- •Unable to receive radical resection;
- •Need of palliative or emergency operation due to lung abscess or hemoptysis;
- •Having received neoadjuvant chemoradiotherapy.
Arms & Interventions
Surgery after conversion therapy
Participants with locally advanced or advanced NSCLC who received first-line treatment have been evaluated as resectable after multidisciplinary discussion involving the department of thoracic surgery, respiratory medicine, radiology and oncology.
Intervention: Surgery (Procedure)
Outcomes
Primary Outcomes
perioperative morbidity
Time Frame: postoperative in-hospital stay up to 30 days
rate of perioperative complications, mainly include: pneumonia, arrhythmia, incision infection, vocal cord paralysis, trachea cannula
Secondary Outcomes
- 1-year overall survival (OS)(1 year after surgery)
- lymph nodes counts(At operation day)
- 3-year overall survival (OS)(3 year after surgery)
- R0 rate(postoperative in-hospital stay up to 30 days)
- operative complications(At operation day)
- postoperative hospital stay(postoperative in-hospital stay up to 30 days)
- 30-day mortality(postoperative in-hospital stay up to 30 days)
- operation time(At operation day)
- blood loss(At operation day)
- 3-year disease-free survival (DFS)(3 year after surgery)
- 1-year disease-free survival (DFS)(1 year after surgery)
Investigators
Hecheng Li M.D., Ph.D
Professor
Ruijin Hospital