Adebrelimab Combined With Neoadjuvant Chemotherapy in Borderline Resectable Locally Advanced Esophageal Squamous Cell Carcinoma

NCT07638436 | Recruiting Phase 2

• 1 other identifier: SL-B2025-491-05
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

This clinical trial aims to preliminarily evaluate the efficacy and safety of adebrelimab combined with albumin-bound paclitaxel and carboplatin as neoadjuvant therapy for borderline resectable locally advanced esophageal squamous cell carcinoma (ESCC). The primary research objectives are to increase the R0 resection rate in such patients, thereby reducing the recurrence rate and improving overall survival (OS), as well as avoiding adverse reactions associated with radiotherapy.

Conditions

Esophageal Squamous Cell Carcinoma (ESCC)

Keywords

Adebrelimab; chemotherapy; neoadjuvent; immune checkpoint inhibitor; borderline resectable

Outcome Measures

Primary Outcomes (1)

• R0 resection rate

  The proportion of patients with tumor margins showing no residual cancer cells under the microscope after surgical resection. That is, the proportion of patients in PPS achieving R0 resection.

  From patient enrollment to two weeks post-surgery

Secondary Outcomes (5)

• Overall survival

  up to 5 years post-surgery

• Progression free survival

  up to 5 years post-surgery

• Pathologic complete response rate

  From patient enrollment to two weeks post-surgery

• Incidence of perioperative complications

  from the first drug administration to within 30 days after the last intended treatment

• Tumor Regression Grade

  From patient enrollment to two weeks post-surgery

Study Arms (1)

Experimental

EXPERIMENTAL

Adebrelimab plus nab-paclitaxel, carboplatin

Drug: Adebrelimab Injection

Interventions

Adebrelimab Injection DRUG

Study participants shall complete the informed consent process and undergo multidisciplinary team (MDT) review for esophageal cancer. Patients confirmed as having borderline resectable disease and meeting all inclusion/exclusion criteria will be enrolled and receive treatment with adebrelimab plus albumin-bound paclitaxel and carboplatin.The treatment regimen is administered in 3-week cycles. Efficacy evaluation will be performed after 2 cycles.

Experimental

Eligibility Criteria

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

You may qualify if:

• Aged between 18 and 75 years old. 3.Histologically confirmed thoracic esophageal squamous cell carcinoma without distant metastasis. Patients are defined as borderline resectable after enhanced computed tomography (CT), and/or endoscopic ultrasonography (EUS), endobronchial ultrasonography (EBUS) and multidisciplinary team (MDT) discussion.
• No prior chemotherapy or radiotherapy. 5.Estimated overall survival of no less than 3 months. 6.Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 or 1.
• Hematological parameters (tested within 7 days): Hemoglobin (Hb) ≥ 90 g/L; Neutrophil count (NE) ≥ 1.5×10⁹/L; Platelet count (PLT) ≥ 100×10⁹/L.
• Hepatic and renal function (tested within 7 days): Total bilirubin ≤ 1.5 × upper limit of normal (ULN); Creatinine ≤ 1.5 × ULN; Aspartate transaminase (AST)/Alanine transaminase (ALT) ≤ 2.5 × ULN; Alkaline phosphatase (ALP) ≤ 5.0 × ULN.
• Absence of severe complications, including active massive gastrointestinal bleeding, perforation, jaundice, intestinal obstruction, and non-neoplastic fever above 38°C.
• Fertile patients must adopt effective contraceptive measures throughout the study period.
• Good treatment compliance, and able to complete follow-up assessments for efficacy and adverse events as required by the protocol.

You may not qualify if:

• Patients with cervical esophageal squamous cell carcinoma.
• Patients with distant metastasis.
• Patients with nearly complete esophageal obstruction confirmed by endoscopy who require interventional therapy for decompression.
• Patients with prior placement of esophageal or tracheal stents.
• Patients with high risk of bleeding or perforation due to obvious tumor invasion into adjacent vital organs (major arteries or trachea), or patients with existing fistula formation.
• Patients with other concurrent primary malignancies (except cured basal cell carcinoma of the skin and carcinoma in situ of the cervix).
• Active autoimmune diseases requiring symptomatic treatment, or a medical history of such diseases within the past 2 years.
• Known history of primary immunodeficiency.
• Confirmed active tuberculosis.
• History of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.
• Interstitial lung disease requiring corticosteroid therapy. 13Known allergy to any monoclonal antibody, chemotherapeutic agents (taxanes, carboplatin), or their excipients.
• Severe cardiac diseases, including documented congestive heart failure, uncontrolled high-risk arrhythmia, medically treated angina pectoris, clinically significant valvular heart disease, history of severe myocardial infarction, and refractory hypertension.
• Chronic diarrhea (≥4 watery stools per day) or renal insufficiency. 16.Active infection or active communicable diseases. 17.Neurological or psychiatric disorders impairing cognitive function. 18.Pregnant or breastfeeding women. 19.Other acute or chronic diseases, psychiatric disorders or abnormal laboratory findings that, in the investigator's judgment, may increase risks related to study participation or study drug administration, or interfere with the interpretation of study results.

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

No. 651 Dongfeng East Road, Guangzhou

Guangzhou, Guangdong, 510000, China

RECRUITING

MeSH Terms

Conditions

Esophageal Squamous Cell Carcinoma

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

Central Study Contacts

Hong Yang, MD, PhD

CONTACT

86-13560405144; yanghong@sysucc.org.cn

Chief physician

CONTACT

86-13560405144

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: May 30, 2026
• First Posted: June 10, 2026
• Study Start (Estimated): June 17, 2026
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 31, 2028
• Last Updated: June 10, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)