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This study used an open single center study design to observe the efficacy and safety of Penpulimab combined with Chemoradiotherapy(CRT) in preoperative T2,3,4aN0-1-2M0 esophageal squamous cell carcinoma (ESCC).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Penpulimab Combined With Chemoradiotherapy(CRT) | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Penpulimab Combined With CRT | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| pathological complete remission(pCR)rate | Proportion of subjects who achieved pathological complete remission (PCR),PCR was defined as the microscopic absence of tumor cells in the pathological evaluation of excised esophageal cancer lesions and regional lymph node samples after surgery. | 3 to 4 months |
| safety(AE or SAE) | Incidence of adverse events or serious adverse events | 2 to 3 years from baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Tumor regression grade(TRG) | Evaluation of the focus of primary tumor after radiotherapy and chemotherapy | 3 to 4 months |
| R0 resection rate | Proportion of subjects reaching R0 resection. resection was defined as no tumor cells remained within 1mm of the two cutting edges of the esophageal cancer lesions removed during the operation. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yang Qian, MD | Contact | 0086-13817929371 | qy19792006@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Jian Wang, MD | Fudan University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhongshan Hospital | Shanghai | Shanghai Municipality | 200000 | China |
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| ID | Term |
|---|---|
| D000077277 | Esophageal Squamous Cell Carcinoma |
| ID | Term |
|---|---|
| D002294 | Carcinoma, Squamous Cell |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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|
| 3 to 4 months |
| Event free survival(EFS) | Date of first administration to date of first recording of relevant events | 2 to 3 years from baseline |
| Overall survival(OS) | Date of first administration to date of death due to any cause | 2 to 3 years from baseline |
| Disease free survival(DFS) | Date from the operation to the first recording of relevant events | 2 to 3 years from baseline |
| D009369 | Neoplasms |
| D018307 | Neoplasms, Squamous Cell |
| D004938 | Esophageal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D006258 | Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |