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Adebrelimab Neoadjuvant Treatment for Resectable ESCC

NCT07388095 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2026-02-04

No results posted yet for this study

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.

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

Sponsors & Collaborators

  • Tianjin Medical University Cancer Institute and Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-02-15
Primary Completion
2027-02-28
Completion
2028-02-28

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07388095 on ClinicalTrials.gov