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.
Subjects signed the informed consent and volunteered to participate in the study.
Esophageal squamous cell carcinoma confirmed by histology or cytology.
Thoracic esophageal squamous cell carcinoma confirmed by CT or pet-CT, which is classified as cII-III (AJCC 8th).
Expect to have R0 resection
anti-tumor interventions such as radiotherapy, chemotherapy, or other medications.
immunosuppressants or systemic glucosteroids (prednisone equivalence> 10mg/d) within 2 weeks before the first administration, inhaled or topical use of glucosteroids (prednisone equivalence>10mg/d) is allowed if no known active autoimmune disease.
live vaccine within 4 weeks before the first administration.
major surgery or major injury within 4 weeks before the first administration.
Single group
Adebrelimab and nab-paclitaxel and carboplatin
DrugAdebrelimab combined with nab-paclitaxel and carboplatin as neoadjuvant therapy
Radiation
Radiationconcurrent chemoradiotherapy
standard oesophagectomy
Procedure/Surgerystandard oesophagectomy
active surveillance
Other interventionactive surveillance
2-year OS rate
An overall survival (OS) is defined as the time from treatment to death, regardless of disease recurrence.
cCR rate
A clinical complete response rate (cCR) is defined as the complete disappearance of tumor lesions.
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.
median OS
An overall survival (OS) is defined as the time from treatment to death, regardless of disease recurrence.
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.
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Zhigang Li
Lead sponsor
Shanghai Chest Hospital
Sponsor institution
This trial is not recruiting at the moment. You can still explore other options:
