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

NCT ID: NCT07119190

Last Updated: 2025-08-12

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 350 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-08-06
• Study Completion Date: 2027-10-30

Brief Summary

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.

Detailed 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.

Conditions

Non-Small Cell Lung Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Prospective cohort

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

No interventions assigned to this group

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beijing Municipal Health Commission

OTHER_GOV

Sponsor Role: collaborator

Peking University People's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Yang Fan, MD

Vice President

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Fan Yang, MD

Role: PRINCIPAL_INVESTIGATOR

Peking University People's Hospital

Central Contacts

Hao Li, MD

Role: CONTACT

lihao_pkuhsc@163.com

+86 13051713494

Tianxiao Han, MD

Role: CONTACT

hantianxiao00@163.com

+86 18811411496

Other Identifiers

BRWEP2024W034080200

Identifier Type: -

Identifier Source: org_study_id