Clinical trial NCT06292052: Relation Between Tumor-draining Lymph Nodes Metastasis Pattern and Non-small Cell Lung Cancer Neoadjuvant Immunotherapy Effectiveness
Official title: Relation Between Tumor-draining Lymph Nodes Metastasis Pattern and Non-small Cell Lung Cancer Neoadjuvant Immunotherapy Effectiveness: A Retrospective Multi-institutional Cohort Analysis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lung Cancer
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
Collaborators: name: Jiangmen Central Hospital
name: Henan Cancer Hospital
First posted: 2024-03-04
Enrollment: 209
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.


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

Primary outcomes:
measure: Complete pathologic response
timeFrame: through study completion, an average of 3 months
Secondary outcomes:
measure: Major pathologic response
timeFrame: through study completion, an average of 3 months
measure: Complete pathologic response in lymph nodes
timeFrame: through study completion, an average of 3 months
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Center
state: Guangdong
Study officials:
References:
citation: 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.
citation: 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.