About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Baseline stage resectable cII/III esophageal squamous cell carcinoma (8th UICC TNM stage);
Failure to receive anti-tumor treatment for esophageal squamous cell carcinoma;
Age range from 18 to 75 years old;
There are no surgical contraindications in the preoperative evaluation of various organ functions;
Disqualifiers
Individuals who have received previous treatment for esophageal cancer (surgery, radiotherapy, chemotherapy, immunotherapy, targeted therapy, etc.);
Not suitable for surgery or with surgical contraindications;
Have a history of other anti PD-L1/PD-1 treatments;
Individuals with immunodeficiency or long-term systemic steroid therapy, or those who have received any immunosuppressive therapy within 7 days prior to receiving the study drug;
Trial design
Single group
Treatments tested in this trial
Combination of pembrolizumab and platinum containing dual drugs
DrugAfter 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
Treatment groups
Trial outcomes
Primary outcomes
Pathological complete remission (pCR)
Defined as the absence of any residual esophageal squamous cell carcinoma cells, including the primary lesion and lymph nodes
Secondary outcomes
Major pathological remission (MPR)
The primary pathological response (MPR) is defined as residual survival tumor during surgery ≤ 10%.
R0 resection rate
Progression free survival (PFS)
Total survival time (OS)
Sponsors and contacts
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