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NOT YET RECRUITING
NCT07584031
PHASE2

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

Sponsor: Tianjin Medical University Cancer Institute and Hospital

View on ClinicalTrials.gov

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.

Official title: A Prospective, Single-Center, Phase II Clinical Trial of Adebrelimab Combined With Full-Course Neoadjuvant Therapy for Watchful Waiting or Surgery in Patients With Resectable Locally Advanced Esophageal Squamous Cell Carcinoma

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

200

Start Date

2026-06-01

Completion Date

2028-12-31

Last Updated

2026-05-13

Healthy Volunteers

No

Conditions

Interventions

DRUG

Combination therapy with chemotherapy and immunotherapy

Adebrelimab Injection,intravenous infusion, Day 1, every 3 weeks for 2 cycles. Albumin-bound paclitaxel 260 mg/m², carboplatin AUC = 5, intravenous infusion, Day 1, every 3 weeks for 2 cycles. Two cycles of chemotherapy combined with immunotherapy.

OTHER

Surgery

surgery