This study is a single arm, open, multicenter phase II study. The main purpose of this study was to evaluate preliminary efficacy and safety of Tislelizumab combined with thoracic radiotherapy as first line therapy for Extensive stage small cell lung cancer.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
Tislelizumab infusion will be administered for 2 years (200mg, day1, Q3W).
Etoposide intravenous infusion will be administered during the induction phase (100mg/㎡, day1-3 Q3W for 4 cycles).
Carboplatin or Cisplatin intravenous infusion will be administered during the induction phase (Carboplatin AUC5, Q3W for 4 cycles; Cisplatin 75mg/㎡, Q3W for 4 cycles).
Jincheng General Hospital
Jincheng, Shanxi, China
RECRUITINGJinzhong third people's hospital
Jinzhong, Shanxi, China
RECRUITINGSecond Hospital of Shanxi Medical University
Taiyuan, Shanxi, China
Progression-free Survival (PFS)
From the date of enrollment to the date of disease progression
Time frame: Up to 2 years
Objective Response Rate (ORR)
ORR as assessed by the Investigator according to RECIST v1.1
Time frame: Up to 2 years
Disease Control Rate (DCR)
DCR as assessed by the Investigator according to RECIST v1.1
Time frame: Up to 2 years
Overall Survival (OS)
From the date of enrollment until death by any cause or last follow-up
Time frame: Up to 2 years
Adverse events
Treatment-related adverse events according to CTCAE 5.0.
Time frame: Up to 2 years
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IMRT 30-45Gy/10-15f
Shanxi Bethune Hospital
Taiyuan, Shanxi, China
RECRUITINGShanxi Hospital of Traditional Chinese Medicine
Taiyuan, Shanxi, China
RECRUITINGTISCO General Hospital
Taiyuan, Shanxi, China
RECRUITING