The study is a prospective, multi-center, open-label, randomized, and controlled phase II clinical trial.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
140
Etoposide and cisplatin (carboplatin) plus Sintilimab induction therapy will be administered for 2 cycles and then thoracic radiotherapy (45 Gy/30 fractions) be administered with concurrent EP/EC chemotherapy for 2cycles. Patients who achieve CR or PR then receive prophylactic cranial irradiation (PCI, 25 Gy/10 fractions).Sintilimab maintenance therapy will be administered once every 3 week for 13 cycles.
Etoposide will be administered IV 100mg/m2 on days 1-3, 22-24, 43-45 and 64-66.
cisplatin will be administered IV 80mg/m2 on days 1, 22, 43 and 64.
Progression-free survival
PFS, defined as the time from the date of randomization to the first date of documented objective progression disease or of death from any cause.
Time frame: 2 years
Overall survival
OS, measured from the date of randomization to the date of death from any cause.
Time frame: 5 years
Overall response rates
ORR, tumor response will be measured by using the RECIST 1.1.
Time frame: 2 years
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Thoracic radiotherapy (45 Gy/30 fractions) and prophylactic cranial irradiation (25 Gy/10 fractions).