This study is a prospective, single center, open label, single arm clinical study. Select resectable locally advanced (cT3-4aN0M0, cT1-3N1-2M0, cII/III stage) esophageal cancer with pathological diagnosis of squamous cell carcinoma for inclusion, receive pembrolizumab combined with platinum containing dual drug (albumin paclitaxel+carboplatin) treatment for 2 courses, and undergo surgery. After surgery, continue pembrolizumab immunotherapy. Using pCR as the main endpoint of the study
This study is a prospective, single center, open label, single arm Phase II clinical study. Patients with locally resectable advanced esophageal squamous cell carcinoma were selected for inclusion in the study, who received a 2-course neoadjuvant treatment with pembrolizumab combined with platinum containing dual drugs. After evaluation, surgery was performed. The efficacy and safety of pembrolizumab combined with chemotherapy neoadjuvant therapy for resectable locally advanced esophageal squamous cell carcinoma were observed, with pCR and MPR as the main research endpoints.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
25
After 2 courses of treatment with a combination of pembrolizumab and platinum containing dual drugs (albumin paclitaxel+carboplatin), surgery was performed and pembrolizumab immunomaintenance therapy continued after surgery
Shanghai General Hospital
Shanghai, Shanghai Municipality, China
RECRUITINGPathological complete remission (pCR)
Defined as the absence of any residual esophageal squamous cell carcinoma cells, including the primary lesion and lymph nodes
Time frame: in two weeks after the surgical resection
Major pathological remission (MPR)
The primary pathological response (MPR) is defined as residual survival tumor during surgery ≤ 10%.
Time frame: in two weeks after the surgical resection
R0 resection rate
Time frame: in two weeks after the surgical resection
Progression free survival (PFS)
Time frame: receiving therapy,up to approximately 2years.
Total survival time (OS)
Time frame: The time from the patient's randomization receiving therapy to death from any cause,up to approximately 2years
Safety (incidence of adverse drug reactions)
Time frame: Randomly group patients to receive treatment for up to two years
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