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The investigators will conduct a single-arm prospective study to evaluate the efficacy and safety of neoadjuvant therapy with adebrelimab (SHR-1316) and chemotherapy in patients with resectable esophageal squamous cell carcinoma (ESCC).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| adebrelimab and chemotherapy | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Immunotherapy: Adebrelimab | Drug | Adebrelimab 1200mg Q3W |
| |
| Measure | Description | Time Frame |
|---|---|---|
| pCR rate | The primary endpoint is a pCR rate, which is defined as the absence of any remaining tumor cells in both the main tumor and the nearby lymph nodes (ypT0N0) as per the AJCC 8th Edition TRG scoring system. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| cCR rate | A clinical complete response rate (cCR) is defined as the complete disappearance of tumor lesions as assessed by enhanced CT, endoscopic ultrasound, and endoscopic biopsy. | 12 months |
| R0 resection rate |
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Inclusion Criteria:
Exclusion Criteria:
Subjects have received or are receiving any of:
Cancer related exclusion criteria
Other criteria
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhigang Li, MD, PhD | Contact | 18960619260 | dr_lizhigang@163.com | |
| Yang Yang | Contact | 86 21-22200000*2116 | yangyang@shsmu.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Chest Hospital | Shanghai | China |
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| chemotherapy: carboplatin plus nab-paclitaxel |
| Drug |
carboplatin plus nab-paclitaxel |
|
A R0 resection rate is defined as the rate of complete tumor removal with negative resection margin microscopically
| 12 months |
| MPR rate | A major pathological response rate (MPR) is defined as the proportion of residual living tumor cells in the post-surgery specimen within the tumor bed being less than or equal to 10%. | 12 months |
| median EFS | An event-free survival (EFS) is defined as the duration from the start of treatment until disease recurrence or death from any cause, whichever occurs first. | 12 months |
| median OS | An overall survival (OS) is defined as the time from treatment to death, regardless of disease recurrence. | 12 months |
| Incidence, type and severity of adverse events as assessed by CTCAE 5.0 | Including adverse events and complications. Incidence of adverse events using CTCAE 5.0; grade 3 treatment-related adverse events and higher-grade will be reported | From date of treatment allocation until surgery was applied during study period or up to at least 90 days after last dose |
| Potential biomarkers such as ctDNA or PD-L1 expression | Potential biomarkers such as ctDNA or PD-L1 expression will be explored and analysed using blood or tissues prior and post-treatment. | 12 months |
| 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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| ID | Term |
|---|---|
| C520255 | 130-nm albumin-bound paclitaxel |
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