Carcinoma, Non-Small-Cell Lung, Neoadjuvant Immunotherapy, Surgery
Conditions
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.
Interventions
None listed
Sponsors
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Histologically confirmed non-small cell lung cancer (NSCLC) * Achieved resectability after neoadjuvant immunotherapy with or without chemotherapy * Initially required pneumonectomy or combined lobectomy based on tumor size and extent, but became suitable for minimally invasive resection after neoadjuvant treatment * Age ≥ 18 years * ECOG performance status score of 0-1 * Complete imaging, pathological, and follow-up data available
Exclusion criteria
* Disease progression (PD) after neoadjuvant therapy * Still required pneumonectomy or combined lobectomy after neoadjuvant therapy, with no reduction in the planned surgical extent * Intraoperative findings indicating that R0 resection was not feasible * Severe cardiopulmonary dysfunction or other complications that made the patient unable to tolerate surgery
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Disease-free survival | 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
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival (OS) | From date of diagnosis until the date of death from any cause, whichever came first, assessed up to 5 years. | OS is defined as the time from surgery time until death from any cause. |
| Pathological Complete Response(pCR) | up to 1 month after surgery | After evaluating the removed tumor tissue and the regional lymph nodes, no residual tumor cells were found. |
| Incidence of perioperative complications | up to 1 month after surgery | 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. |
Countries
China
Outcome results
None listed