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.

N/ANot Yet RecruitingNCT07373899

Cancer Institute and Hospital, Chinese Academy of Medical Sciences354 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

354

Conditions

Carcinoma, Non-Small-Cell Lung Neoadjuvant Immunotherapy Surgery

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Disease-free survival

It refers to the period from the beginning of the study until the recurrence of the disease or any cause of death.

Time frame: Evaluate over a period of up to five years

Secondary Outcomes

Overall Survival (OS)

OS is defined as the time from surgery time until death from any cause.

Time frame: From date of diagnosis until the date of death from any cause, whichever came first, assessed up to 5 years.

Pathological Complete Response(pCR)

After evaluating the removed tumor tissue and the regional lymph nodes, no residual tumor cells were found.

Time frame: up to 1 month after surgery

Incidence of perioperative complications

The perioperative period refers to a certain period before, during and after the surgery. Postoperative pulmonary complications refer to various respiratory system complications that occur in patients after the surgery.