Relation Between Tumor-draining Lymph Nodes Metastasis Pattern and Non-small Cell Lung Cancer Neoadjuvant Immunotherapy Effectiveness

Completed

• Conditions: Lung Cancer
• Interventions: Drug: Immunotherapy

• Registration Number: NCT06292052
• Lead Sponsor: Sun Yat-sen University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-01-01
• Study First Submitted: 2024-02-23
• Primary Completion: 2024-03-01
• Study First Submitted QC: 2024-03-01
• Study First Posted: 2024-03-04
• Study Completion: 2024-04-01
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-10
• Last Update Posted: 2024-05-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 209

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Neoadjuvant immunochemotherapy NSCLC group	Immunotherapy	NSCLC patients who received neoadjuvant immunochemotherapy and underwent surgery.

Primary Outcome Measures

Name	Time	Method
Complete pathologic response	through study completion, an average of 3 months	Tumors with 0% viable tumor cells

Secondary Outcome Measures

Name	Time	Method
Major pathologic response	through study completion, an average of 3 months	Tumors with ≤10% viable tumor cells
Complete pathologic response in lymph nodes	through study completion, an average of 3 months	Tumors with 0% viable tumor cells in lymph nodes

Trial Locations

Locations (1)

Sun Yat-sen University Cancer Center; 🇨🇳 Guangzhou, Guangdong, China