80
Participants
Start Date
August 1, 2023
Primary Completion Date
December 30, 2026
Study Completion Date
June 30, 2027
Envafolimab combined with concurrent chemoradiotherapy (Hypofractionated radiotherapy)
"Envafolimab: 300mg SC d1,Q3W,2 cycles Cisplatin/carboplatin: Cisplatin: 75 mg/m2 IV d1,Q3W ,2 cycles or Carboplatin:AUC=5/6 IV d1,Q3W,2cycles Etoposide: 100mg/m2 IV d1,Q3W ,2 cycles Radiotherapy: Provide a prescription dose of 45Gy at a 95% PTV dose, with a single split dose of 3Gy, once a day, 5 times a week, for a total of 15 times.~Envafolimab maintenance: 300mg,SC, d1. Q3W, up to 2 years or until PD or intolerable."
Envafolimab combined with concurrent chemoradiotherapy (Conventional Radiotherapy)
"Envafolimab: 300mg SC d1,Q3W,2 cycles Cisplatin/carboplatin:Cisplatin:75 mg/m2 IV d1,Q3W ,2 cycles or Carboplatin:AUC=5/6 IV d1,Q3W,2cycles Etoposide: 100mg/m2 IV d1,Q3W ,2 cycles Radiotherapy: Provide a prescription dose of 60Gy at a 95% PTV dose, with a single split dose of 2Gy, once per day, 5 times per week, for a total of 30 times.~Envafolimab maintenance: 300mg,SC, d1. Q3W, up to 2 years or until PD or intolerable."
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
OTHER