A Retrospective, Multicenter Case-control Study of Radiotherapy Combined With Immunotherapy for Brain Metastases of Non-small Cell Lung Cancer
Overview
- Phase
- Not Applicable
- Intervention
- PD-1/PD-L1 inhibitor
- Conditions
- Non Small Cell Lung Cancer
- Sponsor
- Tongji Hospital
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- progression-free surival
- Status
- Suspended
- Last Updated
- 5 years ago
Overview
Brief Summary
This is a Retrospective, Multicenter, Controlled Study to Evaluate Immunotherapy and Radiotherpay for Brain Lesions as a Potential Treatment for Patients with Brain Metastasis in non-small cell lung cancer
Investigators
Eligibility Criteria
Inclusion Criteria
- •Experimental group:
- •18 years old ≤ age ≤ 75 years old, no gender limitation;
- •NSCLC who have received radiotherapy for brain lesions + PD-1/PD-L1 immunotherapy;
- •Histologically confirmed as NSCLC;
- •Imaging confirmed brain metastasis (CT or MRI);
- •The presence of imaging-evaluable lesions can be evaluated in accordance with RECIST 1.1
- •Control group:
- •1 18 years old ≤ age ≤ 75 years old, no gender limitation; 2 NSCLC who has received radiotherapy for brain lesions; 3 Histologically confirmed as non-small cell lung cancer; 4 Imaging confirmed brain metastasis (CT or MRI); 5 The presence of imaging-evaluable lesions can be evaluated in accordance with RECIST 1.1
Exclusion Criteria
- •1 The age is less than 18 years old, regardless of gender; 2 Histologically confirmed as NSCLC 3 Imaging confirmed the absence of brain metastases 4 NSCLC with brain metastasis only received chemotherapy or targeted therapy, and did not receive radiotherapy or immunotherapy
Arms & Interventions
Control group (radiotherapy group)
In non-small cell lung cancer, patients with brain metastases received radiotherapy for brain lesion (without limitation of dose and treatment method for radiotherapy) , but not receiving immunotherapy. Those patients would enter the control group. After patients experiencing disease progression(PD) in this group, follow-up treatment does not include immunotherapy until tumor progression again or death.
Intervention: PD-1/PD-L1 inhibitor
Outcomes
Primary Outcomes
progression-free surival
Time Frame: 3 years
Progression-free survival: From the first treatment to the date of first documentation of disease progression, or death due to any cause
Secondary Outcomes
- overall survival(3 years)