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Phase II Trial of Consolidative Thoracic Radiotherapy for ES-SCLC After Standard Care of Chemo-immunotherapy
Sponsor: Ruijin Hospital
Summary
This is an open-label, single arm Phase II study designed to evaluate the efficacy and safety of thoracic radiotherapy for extensive-stage small-cell lung cancer treated with PD-1/PD-L1 plus etoposide platinum followed by PD-1/PD-L1 maintenance therapy
Official title: Consolidative Thoracic Radiotherapy for Extensive-stage Small-cell Lung Cancer Treated with Chemo-immunotherapy Followed by PD-1/PD-L1 Maintenance Therapy：an Open Label, Single Arm Prospective Trial
Key Details
Gender
All
Age Range
18 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
104
Start Date
2021-01-30
Completion Date
2026-09-30
Last Updated
2024-09-19
Healthy Volunteers
No
Conditions
Interventions
thoracic radiotherapy
Four courses of carboplatin/etoposide/anti-PD-1/PD-L1 every 3 weeks All the enrolled patients will be patients with ES-SCLC who did not have PD (determined as per the RECIST v1.1) after 6 cycle of platinum-based chemotherapy in combination with an anti-PD-1/L1. Then, thoracic radiotherapy of 45 Gy/15 fractions. PD-1/PD-L1 maintenance therapy concurrently and after thoracic radiotherapy at least more than 6 months, or until intolerable toxicity, progressive disease leading to a need for other treatment, or until the patient no longer wishes to continue treatment.
Locations (1)
Ruijin Hospital, Shanghai jiaotong univestigy school of medicine
Shanghai, Shanghai Municipality, China