A Perioperative Comprehensive Diagnosis and Treatment System for Lung Cancer in the Era of Neoadjuvant Immunotherapy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Non-Small Cell Lung Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Construction of a Perioperative Comprehensive Diagnosis and Treatment System for Lung Cancer in the Era of Neoadjuvant Immunotherapy
Overview
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.
Primary outcome measures
- Pathological Complete Response (pCR) [Time frame: At surgery (typically 3-6 months post-treatment initiation)]
Secondary outcome measures (8)
- Major Pathological Response (MPR) [Time frame: At surgery (typically 3-6 months post-treatment initiation)]
- Objective Response Rate (ORR) [Time frame: After two cycles or four cycles of neoadjuvant therapy (each cycle is 21 days).]
- Recurrence-free Survival (RFS) [Time frame: Through study completion, an average of 2 years]
- Overall Survival (OS) [Time frame: Through study completion, an average of 2 years]
- MRD (minimal residual disease) dynamics after neoadjuvant immunotherapy [Time frame: Periprocedural and every three to six months post-treatment (up to three years)]
- Symptom Severity Score [Time frame: Preoperative (T1: 2-4 weeks pre-surgery), postoperative (e.g., T3: 12-24 hours post-surgery, T5: 30 days post-surgery), and up to 90 days post-surgery.]
- Immune-Related Adverse Event (irAE) Incidence [Time frame: Periprocedural and up to 6 months post-treatment.]
- Changes in PD-L1 expression (TPS) and TIL subpopulations (CD8+/FOXP3+ ratios, et al) before and after neoadjuvant immunotherapy [Time frame: Periprocedural.]
Eligibility criteria
Inclusion criteria
- Age ≥ 18 years old;
- NSCLC patients underwent radical surgical resection;
- Adequate clinical-pathologic data, imaging data and follow-up data obtainable for multi-omics analysis;
- Scheduled for or currently receiving neoadjuvant/perioperative immunotherapy.
Exclusion criteria
- Histology of other malignant tumors, including concurrent malignant tumors of other organ systems;
- Unresectable advanced disease (Stage IV) or locally advanced unresectable (Stage IIIC);
- Pregnancy or lactation;
- Insufficient sample quality;
- Severe organ dysfunction (e.g. cardiac or renal insufficiency);
- Other judgments by the Investigator that the patient should not participate in the study.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07119190 · BRWEP2024W034080200