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Neoadjuvant Adebrelimab Plus Chemotherapy for Esophageal Cancer: A Clinical Study | Clinical Trials | Clareo Health

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Neoadjuvant Adebrelimab Plus Chemotherapy for Esophageal Cancer: A Clinical Study

An Exploratory, Single-Arm, Multicenter Clinical Study of Neoadjuvant Adebrelimab Plus Chemotherapy for Locally Advanced Esophageal Squamous Cell Carcinoma

NCT07437898•The Affiliated Hospital of Putian University

View on ClinicalTrials.gov

Summary

This is a domestic exploratory, single-arm clinical study enrolling patients with histologically or cytologically confirmed locally advanced esophageal squamous cell carcinoma (ESCC), aiming to evaluate the efficacy and safety of neoadjuvant adebrelimab plus chemotherapy for locally advanced esophageal squamous cell carcinoma (ESCC).

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Provided written informed consent and voluntarily enrolled in this study;
•Aged 18-75 years, male or female;
•Histologically or cytologically confirmed esophageal squamous cell carcinoma (ESCC);
•Clinical stage: cT1b-cT2N+M0 or cT3-cT4a any N M0;
•At least one measurable lesion per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) criteria: long axis ≥10 mm on spiral CT for target lesions, or short axis ≥15 mm for malignant lymph nodes;
•Predicted to be eligible for R0 resection;
•Eastern Cooperative Oncology Group performance status (ECOG PS) 0-1 (see Appendix 1);
•No prior anti-tumor therapy for esophageal cancer, including radiotherapy, chemotherapy, surgery, etc.;
•Planned to undergo surgical resection after completion of neoadjuvant therapy;
•No contraindications to surgery;
+9 more criteria

Exclusion Criteria

•Significant tumor invasion into adjacent organs of the esophageal lesion (e.g., major arteries or trachea);
•Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage;
•Poor nutritional status with a Body Mass Index \<18.5 kg/m² (BMI \<18.5 kg/m²); subjects whose BMI is corrected with targeted nutritional support prior to randomization may be considered for enrollment at the discretion of the principal investigator;
•History of hypersensitivity to monoclonal antibodies, any component of adebrelimab, paclitaxel, cisplatin, or other platinum-based agents;
•Previous or ongoing receipt of any of the following therapies:
•1. Any radiotherapy, chemotherapy, immunotherapy, targeted therapy, or other antitumor therapy for malignancy;
•2. Systemic immunosuppressive therapy or systemic corticosteroid therapy for immunosuppressive purposes (prednisone \>10 mg/day or equivalent dose) within 2 weeks prior to the first dose of study drug; Inhaled or topical steroids, and corticosteroid replacement therapy at prednisone \>10 mg/day or equivalent dose are permitted in the absence of active autoimmune disease;
•3. Live attenuated vaccine within 4 weeks prior to the first dose of study drug;
•4. Major surgery or severe traumatic injury within 4 weeks prior to the first dose of study drug;
•Any active autoimmune disease or history of autoimmune disease, including but not limited to: interstitial pneumonia, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism; subjects with hypothyroidism controlled by hormone replacement therapy may be considered for enrollment.
+14 more criteria

Locations (1)

The Affiliated Hospital of Putian University

Putian, Fujian, China

Key Dates

Start Date

September 3, 2024

Primary Completion Date

April 1, 2026

Completion Date

December 1, 2026

Last Updated

February 27, 2026

Enrollment

ESTIMATED participants

Conditions

Esophageal Squamous Cell Carcinoma

Interventions

Adebrelimab

DRUG

chemotherapy

DRUG

Contacts

JinBiao Xie

CONTACT

13808598778 jinbiaoxie123@163.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 27, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Neoadjuvant Adebrelimab Plus Chemotherapy for Esophageal Cancer: A Clinical Study

Inclusion Criteria

Exclusion Criteria

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