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.

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorCancer Institute and Hospital, Chinese Academy of Medical Sciences

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial population

All the patients were those admitted to the Thoracic Surgery Department of the Cancer Hospital of Chinese Academy of Medical Sciences.

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

354 Participants
are grouped into 2 trial groups
Group A: Conventional Surgery Group
Group B: Modified/Reduced Surgery Group

Trial outcomes

Primary outcomes

1

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

1

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.
2

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
3

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.

Time frame
up to 1 month after surgery

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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