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The goal of this clinical trial is to assess the 1-year DFS rate of toripalimab adjuvant therapy in participants with resected esophageal squamous cell carcinoma (ESCC) who achieved pCR. The main questions it aims to answer are:
Participants will receive toripalimab 240 mg IV once every 3 weeks for one year or clinical observation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Toripalimab | Experimental |
| |
| control | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TORIPALIMAB INJECTION(JS001 ) | Drug | Participants will receive toripalimab 240 mg IV once every 3 weeks. Treatment continued until disease progression, death, unacceptable toxicity, investigator decision, withdrawal, or completion of 1 years of treatment, whichever occurred first. |
| Measure | Description | Time Frame |
|---|---|---|
| 1-year Disease free survival rate | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| 1, 2, 3 years overall survival rates | 3 years | |
| Distant metastasis-free survival | 2 years | |
| Number of Participants with Adverse Events as a Measure of Safety and Tolerability |
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Inclusion Criteria:
Bone marrow function: neutrophils ≥ 1.5×10(9)/L, platelets ≥ 100×10(9)/L, hemoglobin ≥ 90 g/L Liver function:Total bilirubin ≤ 1.5 x ULN;AST and ALT ≤ 3 x ULN Renal function:Cr ≤ 1.5 x ULN,Ccr ≥ 50 ml/min.
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hebei Medical University Fourth Hospital | Shijiazhuang | Hebei | 050011 | China |
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|
The incidences of adverse events were calculated according to the National Cancer Institute Cancer Common Toxicity Criteria, version 5.0. |
| 1.5 years |
| 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 |
| 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 |
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