Comparison of the Effect of Surgical Resection Based on Lesion Extent Before and After Neoadjuvant Therapy in Patients With Stage II-IIIB Non-Small Cell Lung Cancer: A Single-Center, Real-World, Open-Label Study
Overview
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Enrollment
- 354
- Primary Endpoint
- Disease-free survival
Overview
Brief Summary
This study intends to conduct a prospective, non-interventional study to compare the survival benefits of different surgical resection patterns for patients with non-small cell lung cancer who have achieved partial response (PR) after immunotherapy induction. The study plans to enroll patients suitable for surgery as assessed by radiomics evaluation and multidisciplinary team (MDT) discussion, and will assign them to the modified surgery group and the conventional surgery group based on patient preference. The resection scope in the modified surgery group is more limited compared to conventional surgery, aiming to maximize preservation of pulmonary function while ensuring oncological safety. This study will systematically evaluate the impact of different resection scopes on patient prognosis after neoadjuvant immunotherapy, providing clinical evidence for exploring individualized surgical strategies for non-small cell lung cancer in the era of immunotherapy.
Study Design
- Study Type
- Observational
- Observational Model
- Case Control
- Time Perspective
- Prospective
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Histologically confirmed NSCLC; ② Achieved resectable criteria after neoadjuvant immunotherapy (± chemotherapy); ③ Originally required total lung resection or combined lobectomy based on the size and extent of the lesion, but after neoadjuvant treatment, the condition was suitable for minimally invasive resection; ④ Age ≥ 18 years; ⑤ ECOG score 0-1; ⑥ Complete imaging, pathological and follow-up data.
Exclusion Criteria
- •① Disease progression (PD) after neoadjuvant therapy; ② Those who still require total lung resection or combined lobectomy and whose scope cannot be reduced; ③ During the operation, it is found that R0 resection is impossible; ④ Severe cardiopulmonary dysfunction or other complications make them intolerant to surgery.
Arms & Interventions
Modified/Reduced Surgery Group
Under the premise of ensuring R0 resection, reduce the surgical scope, prefer composite lobectomy or lobectomy to maximize the preservation of pulmonary function.
Conventional Surgery Group
Perform a pneumonectomy or composite lobectomy within the originally planned scope
Outcomes
Primary Outcomes
Disease-free survival
Time Frame: Evaluate over a period of up to five years
It refers to the period from the beginning of the study until the recurrence of the disease or any cause of death.
Secondary Outcomes
- Overall Survival (OS)(From date of diagnosis until the date of death from any cause, whichever came first, assessed up to 5 years.)
- Pathological Complete Response(pCR)(up to 1 month after surgery)
- Incidence of perioperative complications(up to 1 month after surgery)