drugset / Trial / NCT07584031

Adebrelimab Plus Full-course Neoadjuvant Therapy for Resectable Locally Advanced ESCC (Phase 2)

NCT07584031

Phase 2 Not yet recruiting 200 enrolled Tianjin Medical University Cancer Institute and Hospital
RandomizedParallel-groupOpen-labelTreatment

Summary

This is a prospective, single-center, randomized phase 2 study of adebrelimab plus full-course neoadjuvant therapy in resectable locally advanced esophageal squamous cell carcinoma. Patients achieving clinical complete response (cCR) after neoadjuvant treatment will be randomized 1:1 to watchful waiting with 2 cycles consolidation chemo-Immunotherapy or standard surgery. Primary endpoint is 2-year DFS. Secondary endpoints include OS, pCR/MPR, R0 resection rate, safety, and quality of life.

Timeline

Start
2026-06-01
Primary completion
2027-12-31
Completion
2028-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Adebrelimab Monoclonal antibody Intravenous
Subject Carboplatin Small molecule 5 unknown Intravenous
Subject Paclitaxel Small molecule 260 mg/m2 Intravenous