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The goal of this clinical trial is to evaluate the efficacy and safety of sintilimab as adjuvant therapy in node-positive esophageal squamous cell carcinoma after radical surgery without neoadjuvant therapy. The main question it aims to answer is:
• Efficacy of sintilimab as adjuvant therapy Participants will receive sintilimab 200 mg once on day 1, every 21 days(Q3W).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental group | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| sintilimab | Drug | 200 mg once on day 1, every 21 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Disease-free survival (DFS) | From date of randomization until the date of first documented progression | assessed up to 36months |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival (OS) | From date of randomization until the date of death from any cause | assessed up to 60 months |
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Inclusion Criteria:
Signed an Informed Consent Form
Participant type and target disease characteristics:
ECOG PS 0-1
Histologically confirmed T1-3N+M0 thoracic esophageal squamous cell cancer (AJCC 8th)
can tolerate radical resection of esophageal cancer
Resection must be performed within 4-12 weeks prior to enrollment
All participants must be confirmed disease-free by physical and imaging examinations within 4 weeks prior to enrollment. Imaging examinations must include CT/MRI scans of the neck, chest and abdomen.
All baseline laboratory tests will be evaluated as required and results should be available within 28 days prior to enrollment. Laboratory test values must be selected according to the following criteria (CTCAE V5.0):
Age and fertility status:
Exclusion Criteria:
Target disease
Medical history and concurrent diseases
If there is no active autoimmune disease, inhaled or topical steroid hormones are permitted, and daily>10 mg prednisone equivalent dose of adrenal hormone replacement therapy.
Physical and laboratory examination
Allergies and adverse drug reactions
Other exclusion criteria
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Changchun Wang, MD | Contact | 13606520363 | wangcc@zjcc.org.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhejiang Cancer Hospital | Recruiting | Hangzhou | Zhejiang | 310022 | 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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| ID | Term |
|---|---|
| C000632826 | sintilimab |
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| 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 |