Neoadjuvant Anti-PD-1 Therapy in Early Stage Non-small-cell Lung Cancer Presenting as Synchronous Ground-glass Nodules: a Pilot Study
Overview
- Phase
- Phase 2
- Intervention
- Tislelizumab Injection
- Conditions
- Multiple Pulmonary Nodules
- Sponsor
- XiangNing Fu
- Enrollment
- 12
- Locations
- 1
- Primary Endpoint
- Objective Response Rate
- Status
- Completed
- Last Updated
- 7 months ago
Overview
Brief Summary
Neoadjuvant Immunotherapy in Early Stage Non-small-cell Lung Cancer Presenting as Synchronous Ground-glass Nodules: a pilot study
Detailed Description
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
Investigators
XiangNing Fu
Professor
Tongji Hospital
Eligibility Criteria
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
Arms & Interventions
neoadjuvant PD-1 group
receiving neoadjuvant therapy of programmed death-1 (pd-1) immune checkpoint inhibitor
Intervention: Tislelizumab Injection
Outcomes
Primary Outcomes
Objective Response Rate
Time Frame: twelve weeks
Secondary Outcomes
- treatment-related adverse events(three months)