About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Adebrelimab and nab-paclitaxel and carboplatin
- Radiation
- standard oesophagectomy
- active surveillance
Treatment groups
Sponsors and collaborators
Zhigang Li
Lead sponsor
Shanghai Chest Hospital
Sponsor institution