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NCT Number: NCT06292052

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

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.

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Key information

Conditions

Lung Cancer Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Immunotherapy

Drug

Received neoadjuvant chemotherapy plus immunotherapy

Other names: Chemotherapy

Primary outcomes

  1. Complete pathologic response

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

    Tumors with 0% viable tumor cells

Secondary outcomes

  1. Major pathologic response

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

    Tumors with ≤10% viable tumor cells

  2. Complete pathologic response in lymph nodes

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

    Tumors with 0% viable tumor cells in lymph nodes

Sponsors and collaborators

Lead sponsor

Sun Yat-sen University

Other

Collaborators

  • Henan Cancer Hospital
  • Jiangmen Central Hospital

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2024
Study completion
2024
First posted
Mar 4, 2024
Registry last updated
May 14, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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