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).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
36
Adebrelimab 1200mg Q3W
carboplatin plus nab-paclitaxel
Shanghai Chest Hospital
Shanghai, China
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.
Time frame: 12 months
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.
Time frame: 12 months
R0 resection rate
A R0 resection rate is defined as the rate of complete tumor removal with negative resection margin microscopically
Time frame: 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%.
Time frame: 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.
Time frame: 12 months
median OS
An overall survival (OS) is defined as the time from treatment to death, regardless of disease recurrence.
Time frame: 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
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Time frame: 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.
Time frame: 12 months