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

XiangNing Fu12 enrolled

Overview

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

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Multiple Pulmonary Nodules

Interventions

Tislelizumab InjectionDRUG

Patients in the experimental group receive Tislelizumab Injection

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Tongji Hospital Affiliated to Huazhong Technology Hospital

Wuhan, Hubei, China

Outcomes

Primary Outcomes

Objective Response Rate

Time frame: twelve weeks

Secondary Outcomes

treatment-related adverse events

Time frame: three months

Data from ClinicalTrials.gov

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