Pathological Tumor and Lymph Node Responses After Neoadjuvant Immunochemotherapy in Initially-unresectable NSCLC

NCT ID: NCT05637580

Last Updated: 2022-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

110 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-05-20

Study Completion Date

2022-07-01

Brief Summary

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This is a real-world study with the largest sample size investigating the pathological tumor and lymph node responses to neoadjuvant immunochemotherapy in non-small cell lung cancer to date. Patients with initially unresectable NSCLC underwent immunochemotherapy and response to treatment was assessed after every two treatment cycles. Clinicopathologic features of patients including epidemiological data, clinical manifestations, operation strategies, pathological findings, and prognostic information were recorded and evaluated.

Detailed Description

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Conditions

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Non Small Cell Lung Cancer Immunotherapy Chemotherapy Tumour, Residual

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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combined well responder

Both primary tumor and nodal response achieve major pathological response (MPR).

Timing of drug administration

Intervention Type DRUG

The effect of drug administration timing on tumor and lymph node responses was observed.

poor responder

Primary tumor or/and nodal response can not achieve MPR.

Timing of drug administration

Intervention Type DRUG

The effect of drug administration timing on tumor and lymph node responses was observed.

Interventions

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Timing of drug administration

The effect of drug administration timing on tumor and lymph node responses was observed.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients with stage III NSCLC who received neoadjuvant immunochemotherapy.
* early-stage NSCLC patients who were initially unresectable.
* 18 years of age or older.
* Karnofsky performance status (KPS) score of 100 or 90.

Exclusion Criteria

* Patients with stage IV NSCLC
* Patients with known ALK translocations or EGFR mutations.
* Karnofsky performance status (KPS) score \<90.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Guangdong Provincial People's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Guibin Qiao, MD

Role: STUDY_DIRECTOR

Guangdong Provincial People's Hospital

Locations

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Guangdong Provincial People's Hospital

Guangzhou, Guangdong, China

Site Status

Countries

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China

Other Identifiers

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LUNGTN

Identifier Type: -

Identifier Source: org_study_id

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