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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Combination of pembrolizumab and platinum containing dual drugs | Experimental | After 2 courses of treatment with pembrolizumab combined with platinum containing dual drugs (albumin paclitaxel+carboplatin), surgery was performed, and postoperative pembrolizumab immunomaintenance therapy continued |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Combination of pembrolizumab and platinum containing dual drugs | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Pathological complete remission (pCR) | Defined as the absence of any residual esophageal squamous cell carcinoma cells, including the primary lesion and lymph nodes | in two weeks after the surgical resection |
| Measure | Description | Time Frame |
|---|---|---|
| Major pathological remission (MPR) | The primary pathological response (MPR) is defined as residual survival tumor during surgery ≤ 10%. | in two weeks after the surgical resection |
| R0 resection rate |
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Inclusion Criteria:
Exclusion Criteria:
Exit criteria:
Withdrawal cases refer to subjects who have stopped continuing treatment in clinical research due to various reasons. Subjects who experience the following situations will withdraw from the investigational treatment:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jiang Fan, MD | Contact | 15901013210 | fan_jiang@tongji.edu.cn | |
| Fu Yang, DM | Contact | 18101839885 |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai General Hospital | Recruiting | Shanghai | Shanghai Municipality | 200080 | China |
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| in two weeks after the surgical resection |
| Progression free survival (PFS) | receiving therapy,up to approximately 2years. |
| Total survival time (OS) | The time from the patient's randomization receiving therapy to death from any cause,up to approximately 2years |
| Safety (incidence of adverse drug reactions) | Randomly group patients to receive treatment for up to two years |
| ID | Term |
|---|---|
| D004938 | Esophageal Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
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