Neoadjuvant Immunotherapy in Early Stage Non-small-cell Lung Cancer Presenting as Synchronous Ground-glass Nodules

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

Clinical Phase

PHASE2

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-01

Study Completion Date

2025-05-30

Brief Summary

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Neoadjuvant Immunotherapy in Early Stage Non-small-cell Lung Cancer Presenting as Synchronous Ground-glass Nodules: a pilot study

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Detailed Description

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In many cases, non-small-cell lung cancer(NSCLC) manifested as synchronous ground-glass nodules(GGNs) and makes complete surgical resection impossible. At the same time, there is no good solution for the remaining GGNs after resection of the main lesion. Theoretically, pre-operative anti-PD-1 therapy is optimal for promoting anti-tumor immune response on the basis of maximum tumor mutational burden (TMB). In addition, neoadjuvant immunotherapy should have long-term anti-tumor effect even after surgery, because tumor recurrence may cause memory cells activation and differentiation. This is a pilot study to analysis the pathological remission rate of neoadjuvant immunotherapy and adverse events related to the treatment

Conditions

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Multiple Pulmonary Nodules

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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neoadjuvant PD-1 group

receiving neoadjuvant therapy of programmed death-1 (pd-1) immune checkpoint inhibitor

Group Type EXPERIMENTAL

Tislelizumab Injection

Intervention Type DRUG

Patients in the experimental group receive Tislelizumab Injection

Interventions

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Tislelizumab Injection

Patients in the experimental group receive Tislelizumab Injection

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* not less than two GGNs on chest CT
* at least one lesion is diagnosed as NSCLC from biopsy pathology
* no contraindication for surgery
* ECOG score of 0 or 1
* no detectable evidence of distant metastasis

Exclusion Criteria

* medical history of malignancy
* pregnant or breeding period
* severe organ failure (heart, liver, kidney, and lung)
* high risk of cerebral-cardiovascular evens
* infection out of control
* received or receiving chemo- and radiotherapy
* history of severe reaction due to allergy or hypersensitivity
* severe mental disorder
* currently been enrolled in other trials
* autoimmune or chronic inflammatory disease

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No