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

NCT06292052 | Completed

• 1 other identifier: NSCLC-TDLN-001
• Study Type: observational
• Target: 209
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Complete pathologic response

  Tumors with 0% viable tumor cells

  through study completion, an average of 3 months

Secondary Outcomes (2)

• 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 Arms (1)

Neoadjuvant immunochemotherapy NSCLC group

NSCLC patients who received neoadjuvant immunochemotherapy and underwent surgery.

Drug: Immunotherapy

Interventions

Immunotherapy DRUG

Received neoadjuvant chemotherapy plus immunotherapy

Also known as: Chemotherapy

Neoadjuvant immunochemotherapy NSCLC group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with resectable NSCLC (clinically staged as T1-4N0-2M0) who underwent neoadjuvant chemoimmunotherapy followed by surgery between January 2017 and January 2024 in Sun Yat-sen University Cancer Center were retrospectively reviewed.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sun Yat-sen University: lead
• Jiangmen Central Hospital: collaborator
• Henan Cancer Hospital: collaborator

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

Location

Related Publications (2)

• Rahim MK, Okholm TLH, Jones KB, McCarthy EE, Liu CC, Yee JL, Tamaki SJ, Marquez DM, Tenvooren I, Wai K, Cheung A, Davidson BR, Johri V, Samad B, O'Gorman WE, Krummel MF, van Zante A, Combes AJ, Angelo M, Fong L, Algazi AP, Ha P, Spitzer MH. Dynamic CD8+ T cell responses to cancer immunotherapy in human regional lymph nodes are disrupted in metastatic lymph nodes. Cell. 2023 Mar 16;186(6):1127-1143.e18. doi: 10.1016/j.cell.2023.02.021.

  PMID: 36931243 RESULT

• Prokhnevska N, Cardenas MA, Valanparambil RM, Sobierajska E, Barwick BG, Jansen C, Reyes Moon A, Gregorova P, delBalzo L, Greenwald R, Bilen MA, Alemozaffar M, Joshi S, Cimmino C, Larsen C, Master V, Sanda M, Kissick H. CD8+ T cell activation in cancer comprises an initial activation phase in lymph nodes followed by effector differentiation within the tumor. Immunity. 2023 Jan 10;56(1):107-124.e5. doi: 10.1016/j.immuni.2022.12.002. Epub 2022 Dec 28.

  PMID: 36580918 RESULT

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Immunotherapy; Drug Therapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Immunomodulation; Biological Therapy; Therapeutics

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 23, 2024
• First Posted: March 4, 2024
• Study Start: January 1, 2017
• Primary Completion: March 1, 2024
• Study Completion: April 1, 2024
• Last Updated: May 14, 2024

Record last verified: 2024-05

Locations

CN (1)