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NOT YET RECRUITING
NCT07388095
NA

Adebrelimab Neoadjuvant Treatment for Resectable ESCC

Sponsor: Tianjin Medical University Cancer Institute and Hospital

View on ClinicalTrials.gov

Summary

This is a prospective, phase II, exploratory clinical trial. The study aims to evaluate the efficacy and safety of in combination adebrelimab with nimotuzumab and chemotherapy as neoadjuvant therapy in patients with resectable esophageal squamous cell carcinoma. The primary endpoint is pCR ( pathological complete response), evaluating the efficacy of adebrelimab in combination with nimotuzumab and neoadjuvant chemotherapy in patients with resectable esophageal squamous cell carcinoma. After the primary objective is achieved, EFS (event free survival ), R0 resection rate, MPR (major pathological response), OS (overall survival), and safety will be assessed as key secondary objectives. The study plans to enroll 22 patients with resectable esophageal squamous cell carcinoma. The study is divided into a screening period, a treatment period, and a follow-up period. Subjects will enter the screening period after signing informed consent. Subjects who pass the screening assessment will be enrolled in the study. Eligible subjects will receive two cycles of neoadjuvant therapy with adebrelimab, nimotuzumab, nab-paclitaxel, and cisplatin. Esophagectomy will be performed after two cycles of neoadjuvant therapy (4-6 weeks after the last dose). Researchers will determine subsequent treatment based on postoperative pathology. After treatment (surgery), safety and efficacy follow-ups will commence. When a subject first experiences disease progression as assessed by the investigator according to RECIST v1.1, confirmation is required after 4-6 weeks (except for rapid or significant clinical progression). Subjects whose disease progression is not confirmed by imaging after 4-6 weeks may continue treatment if their clinical symptoms remain stable, as determined by the investigator, until imaging-confirmed disease progression occurs, or other termination criteria as specified in the protocol are met, whichever occurs first.

Official title: Neoadjuvant Treatment With Adebrelimab in Combination With Nimotuzumab and Chemotherapy for Resectable Esophageal Squamous Cell Carcinoma: A Single-arm, Exploratory Phase II Clinical Study

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

22

Start Date

2026-02-15

Completion Date

2028-02-28

Last Updated

2026-02-04

Healthy Volunteers

No

Conditions

Interventions

DRUG

Adebrelimab (PD-L1 inhibitor)

Adebrelimab: 1200mg, iv, d1, Q3W, 2cycles Nimotuzumab:400 mg, d1,d8, Q3W, 2cycles Cisplatin: 75mg/m2,d1, Q3W, 2cycles Albumin-bound paclitaxel: 260 mg/m2, d1, Q3W, 2cycles