Active Surveillance After Neoadjuvant Adebrelimab Combined With Chemoradiotherapy for Resectable ESCC

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorZhigang Li

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

164 Participants
are divided into 1 treatment group

Sponsors and collaborators

Zhigang Li

Lead sponsor

Shanghai Chest Hospital

Sponsor institution