Relation Between Tumor-draining Lymph Nodes Metastasis Pa... | NCT06292052

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

NCT06292052

Sponsor

Sun Yat-sen University

Status

Completed

Last Update Posted

May 14, 2024Actual

Enrollment

209Actual

Phase

Not provided

Conditions

Lung Cancer

Interventions

Immunotherapy

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2017Actual

Primary Completion Date

Mar 1, 2024Actual

Completion Date

Apr 1, 2024Actual

First Submitted Date

Feb 23, 2024

First Submission Date that Met QC Criteria

Mar 1, 2024

First Posted Date

Mar 4, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 10, 2024

Last Update Posted Date

May 14, 2024Actual

Name	Class
Jiangmen Central Hospital	OTHER
Henan Cancer Hospital	OTHER_GOV

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

209Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Neoadjuvant immunochemotherapy NSCLC group		NSCLC patients who received neoadjuvant immunochemotherapy and underwent surgery.	Drug: Immunotherapy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Immunotherapy	Drug	Received neoadjuvant chemotherapy plus immunotherapy	Neoadjuvant immunochemotherapy NSCLC group

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sun Yat-sen University Cancer Center		Guangzhou	Guangdong	510060	China

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
36931243	Result	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.
36580918

ID	Term
D012142	Respiratory Tract Neoplasms
D013899	Thoracic Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

ID	Term
D007167	Immunotherapy
D004358	Drug Therapy

ID	Term
D056747	Immunomodulation
D001691	Biological Therapy
D013812	Therapeutics