A Perioperative Comprehensive Diagnosis and Treatment System for Lung Cancer in the Era of Neoadjuvant Immunotherapy

Peking University

Status: Not yet enrolling

Conditions: Non-Small Cell Lung Cancer

Study type: Observational

Funder types: Other

Identifiers

NCT07119190

BRWEP2024W034080200

Details and patient eligibility

About

The goal of this study is to develop and refine an integrated minimally invasive care pathway for resectable lung cancer in the immunotherapy era, establishing a novel precision perioperative immunotherapy paradigm encompassing original techniques and clinical applications.

Full description

Lung cancer remains the leading cause of cancer-related mortality in China and globally, imposing a substantial disease burden on society. Although comprehensive treatment strategies centered on surgery have improved patient outcomes, and perioperative immunotherapy-particularly immune checkpoint inhibitors-has profoundly reshaped the therapeutic landscape, significant knowledge gaps and critical challenges persist in this field. These challenges include uncertain beneficiary populations, poorly understood immune mechanisms, inaccurate efficacy prediction, difficult determination of resection margins, controversial efficacy assessment, and lack of effective early warning for adverse reactions.

This study will systematically identify biomarkers for early diagnosis and recurrence monitoring through multi-omic analysis of peripheral blood immune cell subsets and non-invasive liquid biopsies; investigate the tumor immune microenvironment's role in immunotherapy response mechanisms and predict treatment efficacy via multi-omic studies of tissue specimens; develop novel AI- and radiomics-assisted pathological assessment systems and prognostic prediction models; implement perioperative symptom assessment for timely identification of immune-related adverse events (irAEs) while conducting prehabilitation training for perioperative nursing care.

Enrollment: 350 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age ≥ 18 years old;
2. NSCLC patients underwent radical surgical resection;
3. Adequate clinical-pathologic data, imaging data and follow-up data obtainable for multi-omics analysis;
4. Scheduled for or currently receiving neoadjuvant/perioperative immunotherapy.

Exclusion criteria

1. Histology of other malignant tumors, including concurrent malignant tumors of other organ systems;
2. Unresectable advanced disease (Stage IV) or locally advanced unresectable (Stage IIIC);
3. Pregnancy or lactation;
4. Insufficient sample quality;
5. Severe organ dysfunction (e.g. cardiac or renal insufficiency);
6. Other judgments by the Investigator that the patient should not participate in the study.

Trial design

350 participants in 1 patient group

Prospective cohort

Description:

Non-small cell Lung cancer patients receiving neoadjuvant immunotherapy and surgery