Neoadjuvant Adebrelimab Plus Chemotherapy for Esophageal Cancer: A Clinical Study

NCT07437898 | Recruiting Phase 2

• 1 other identifier: 2024123
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Esophageal Squamous Cell Carcinoma

Keywords

Adebrelimab; chemotherapy; Neoadjuvant

Outcome Measures

Primary Outcomes (1)

• Pathological Complete Response Rate (pCR)

  Four weeks after surgery

Secondary Outcomes (6)

• Surgical R0 resection rate

  Four weeks after surgery

• Main pathological relief (MPR)

  Four weeks after surgery

• Disease-Free Survival (DFS)

  24-months

• Objective Response Rate (ORR)

  Up to 3 months per two cycles (21 days per cycle)]

• Overall Survival (OS)

  24-months

Study Arms (1)

Adebrelimab in combination chemotherapy

EXPERIMENTAL

Drug: Adebrelimab; Drug: chemotherapy

Interventions

chemotherapy DRUG

nanoparticle albumin-bound paclitaxel (Nab-paclitaxel) 100 mg/m² on Days 1 and 8 (D1/D8), intravenous infusion, every 3 weeks (Q3W); Cisplatin 75 mg/m² on Days 1, 2 and 3 (D1/D2/D3), intravenous infusion, every 3 weeks (Q3W).

Adebrelimab in combination chemotherapy

Adebrelimab DRUG

Adebrelimab 1200 mg or 20 mg/kg, intravenous infusion, every 3 weeks (Q3W);

Adebrelimab in combination chemotherapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• Adequate organ function, as defined below:
• Hematologic parameters (no blood products, colony-stimulating factors, leukocyte-raising agents, platelet-raising agents, or anti-anemia agents permitted within 14 days prior to the first dose of study drug):
• White blood cell (WBC) count ≥ 3.0×10⁹/L Absolute neutrophil count (ANC) ≥ 1.0×10⁹/L Platelet count ≥ 80×10⁹/L Hemoglobin ≥ 90 g/L
• Blood biochemistry:
• Total bilirubin ≤ 1.5×ULN Alanine transaminase (ALT) ≤ 2.5×ULN; aspartate transaminase (AST) ≤ 2.5×ULN Serum creatinine ≤ 1.5×ULN, or creatinine clearance ≥ 50 mL/min (calculated by the Cockcroft-Gault formula, see Appendix 2)

You may not qualify if:

• 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:
• Any radiotherapy, chemotherapy, immunotherapy, targeted therapy, or other antitumor therapy for malignancy;
• 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;
• Live attenuated vaccine within 4 weeks prior to the first dose of study drug;
• 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.
• Subjects with fully resolved psoriasis or childhood asthma/allergies requiring no adult intervention may be considered, while those requiring medical intervention with bronchodilators are excluded;
• History of immunodeficiency, including positive HIV test, other acquired or congenital immunodeficiency disorders, history of organ transplantation, or allogeneic bone marrow transplantation;
• Poorly controlled cardiac symptoms or diseases, including but not limited to:
• Heart failure of New York Heart Association Class II (NYHA Class II) or higher;
• Unstable angina pectoris;

Sponsors & Collaborators

• The Affiliated Hospital of Putian University: lead

Study Sites (1)

The Affiliated Hospital of Putian University

Putian, Fujian, 351100, China

RECRUITING

MeSH Terms

Conditions

Esophageal Squamous Cell Carcinoma

Interventions

Drug Therapy

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Squamous Cell; Esophageal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Central Study Contacts

JinBiao Xie

CONTACT

13808598778; jinbiaoxie123@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2026
• First Posted: February 27, 2026
• Study Start: September 3, 2024
• Primary Completion: April 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)