This single center, prospective, single arm clinical study aims to evaluate the clinical efficacy and safety of Envafolimab combined with albumin bound paclitaxel and carboplatin as neoadjuvant therapy for locally advanced esophageal squamous cell carcinoma.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
26
Albumin bound paclitaxel: administered on days 1, 8, and 15, 100 mg/m2, IV , treated for 3 weeks, followed by a 1-week rest period; Carboplatin: administered on days 1, AUC 5, treated for 3 weeks, followed by a 1-week rest period.
Shanghai Zhongshan Hospital
Shanghai, Shanghai Municipality, China
RECRUITINGPathological complete response (pCR) rate
Time frame: From enrollment to the end of treatment at 8 weeks
R0 resection rate
Time frame: From enrollment to the end of treatment at 10 weeks
Major pathological response rate
Time frame: From enrollment to the end of treatment at 8 weeks
ORR
Objective response rate
Time frame: From enrollment to the end of Cycle 2 (each cycle is 28 days)
3y-RFS rate
3-year recurrence free survival rate
Time frame: From enrollment until the date of first documented recurrence or date of death from any cause, whichever came first, assessed up to 36 months
3y-OS rate
3-year Overall survival rate
Time frame: From enrollment until the date of death from any cause, assessed up to 36 months
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