Active Surveillance After Neoadjuvant Adebrelimab Combined With Chemoradiotherapy for Resectable … (NCT06861894) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Active Surveillance After Neoadjuvant Adebrelimab Combined With Chemoradiotherapy for Resectable ESCC
China164 participantsStarted 2025-07
Plain-language summary
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.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. 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
✓. In age from 18 to 75.
✓. ECOG PS: 0\~1.
✓. Have not received any anti-tumor treatment for esophageal cancer in the past, including radiotherapy, chemotherapy, surgery, etc.
✓. No contraindications to surgery.
Exclusion criteria
✕. Subjects have received or are receiving any of:
✕. 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.