In this prospective trial, patients demonstrating clinical complete response (cCR) as determined by a standard response assessment protocol (incorporating clinical and molecular diagnostic methods) will be offered organ-sparing management following neoadjuvant therapy with adebrelimab (anti-PD-L1) concurrent with chemoradiotherapy. The primary endpoint is 2-year overall survival rate in this watch-and-wait cohort.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
164
Adebrelimab combined with nab-paclitaxel and carboplatin as neoadjuvant therapy
concurrent chemoradiotherapy
standard oesophagectomy
Shanghai Chest Hospital
Shanghai, China
2-year OS rate
An overall survival (OS) is defined as the time from treatment to death, regardless of disease recurrence.
Time frame: 24 months
cCR rate
A clinical complete response rate (cCR) is defined as the complete disappearance of tumor lesions.
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: 24 months
median OS
An overall survival (OS) is defined as the time from treatment to death, regardless of disease recurrence.
Time frame: 24 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 adverse events and higher-grade will be reported.
Time frame: 24 months
quality of life (QOL)
Evaluate quality of life using EORTC QLQ-C30
Time frame: 24 months
quality of life (QOL) assessed by EORTC QLQ-OES18
Evaluate quality of life using EORTC QLQ-OES18
Time frame: 24 months
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active surveillance