Skip to main content
Clinical Trials/NCT06292052
NCT06292052
Completed
Not Applicable

Relation Between Tumor-draining Lymph Nodes Metastasis Pattern and Non-small Cell Lung Cancer Neoadjuvant Immunotherapy Effectiveness: A Retrospective Multi-institutional Cohort Analysis

Sun Yat-sen University1 site in 1 country209 target enrollmentJanuary 1, 2017
ConditionsLung Cancer
InterventionsImmunotherapy

Overview

Phase
Not Applicable
Intervention
Immunotherapy
Conditions
Lung Cancer
Sponsor
Sun Yat-sen University
Enrollment
209
Locations
1
Primary Endpoint
Complete pathologic response
Status
Completed
Last Updated
last year

Overview

Brief Summary

The goal of this retrospective cohort analysis is to discover the impact of the involvement extent of tumor-draining lymph nodes (TDLNs) in patients who received neoadjuvant immunochemotherapy. The main question it aims to answer is the role of TDLN in the prediction of treatment effectiveness. Researches will compare tumor-draining lymph nodes metastasis (mTDLNs) group and non-draining lymph nodes metastasis (mNDLNs) group to see whether different metastatic patterns of mediastinal lymph nodes can indicate the treatment effectiveness.

Registry
clinicaltrials.gov
Start Date
January 1, 2017
End Date
April 1, 2024
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Sponsor
Sun Yat-sen University
Responsible Party
Principal Investigator
Principal Investigator

Hao Long

Professor

Sun Yat-sen University

Eligibility Criteria

Inclusion Criteria

  • pathologically-confirmed diagnosis of NSCLC by pretreatment biopsy
  • clinically staged as T1-4N0-2M0
  • having undergo neoadjuvant chemoimmunotherapy
  • the agents of immune checkpoint inhibitors (ICIs) belong to PD-1/L1 inhibitors
  • having undergo surgery with lymph nodes (LNs) dissection
  • having postoperative pathology reports with evaluation of primary tumor and LNs response
  • having accessible pretreatment and preoperative radiology examinations imaging or reports

Exclusion Criteria

  • using PD-1/L1 inhibitors in the phase of clinical trials
  • the agents of neoadjuvant therapy including angiogenesis inhibitors
  • having undergone radiotherapy to treat primary tumor or metastatic LNs before surgery

Arms & Interventions

Neoadjuvant immunochemotherapy NSCLC group

NSCLC patients who received neoadjuvant immunochemotherapy and underwent surgery.

Intervention: Immunotherapy

Outcomes

Primary Outcomes

Complete pathologic response

Time Frame: through study completion, an average of 3 months

Tumors with 0% viable tumor cells

Secondary Outcomes

  • Major pathologic response(through study completion, an average of 3 months)
  • Complete pathologic response in lymph nodes(through study completion, an average of 3 months)

Study Sites (1)

Loading locations...

Similar Trials