Adebrelimab Combined With Neoadjuvant Chemoradiotherapy for Esophageal Squamous Cell Carcinoma

NCT07595770 | Recruiting Phase 2

• 1 other identifier: SYSKY-2025-799-02
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to systematically evaluate the safety and efficacy of adalimumab combined with paclitaxel, carboplatin, and short-course radiotherapy in the neoadjuvant treatment of esophageal squamous cell carcinoma.

Conditions

Esophageal Squamous Cell Carcinoma (ESCC)

Keywords

chemotherapy; radiotherapy; immune checkpoint inhibitors; adebrelimab

Outcome Measures

Primary Outcomes (1)

• Pathological complete response (pCR)

  The proportion of subjects with no residual viable tumor cells(ypT0N0) in the primary tumor and lymph nodes; that is, the proportion of patients who have achieved complete remission among PPS(Per-Protocol Set).

  From patient enrollment to the end of surgery

Secondary Outcomes (7)

• R0 resection rate

  From patient enrollment to the end of surgery

• Disease free survival (DFS)

  up to 24 months post-surgery

• Overall survival (OS)

  up to 24 months after surgery

• Major pathological remission (MPR)

  From patient enrollment to the end of surgery

• Progression free survival (PFS)

  Up to 24 months post-surgery

Study Arms (1)

Adebrelimab and nab-paclitaxel plus carboplatin followed by radiotherapy

EXPERIMENTAL

Patients would receive Adebrelimab (IV 1200mg d1) and nab-paclitaxel (IV 220 mg/m²d1) plus carboplatin (AUC = 5, d1) for two 21-day cycles, followed by one week off for radiotherapy (2.5 ⨉12 Gy). After radiotherapy, another cycle of Adebrelimab (IV 1200mg d1) would be given. 4 to 6 weeks after completing the neoadjuvant therapy, patients would undergo esophagectomy.

Drug: • Adebrelimab and nab-paclitaxel, carboplatin in Combination With radiotherapy

Interventions

• Adebrelimab and nab-paclitaxel, carboplatin in Combination With radiotherapy DRUG

Patients would receive Adebrelimab (IV 1200mg d1) and nab-paclitaxel (IV 220 mg/m²d1) plus carboplatin (AUC = 5, d1) for two 21-day cycles, followed by one week off for radiotherapy (2.5 ⨉12 Gy). After radiotherapy, another cycle of Adebrelimab (IV 1200mg d1) would be given. 4 to 6 weeks after completing the neoadjuvant therapy, patients would undergo esophagectomy.

Adebrelimab and nab-paclitaxel plus carboplatin followed by radiotherapy

Eligibility Criteria

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

You may qualify if:

• \- 1. Provided informed consent and sign the informed consent form;
• \. Male or female, Aged 18-75 years (counted on the date of signing informed consent);
• \. Pathological confirmed ESCC;
• \. Patients assessed by thoracic oncologists as resectable without distant metastasis
• \. Patients evaluate with clinical staging of T1-4aN1-3M0 or T3-4aN0M0(AJCC 9.0) based on imaging and pathological examination results;
• \. Have at least one assessable lesion according to the RECIST V1.1
• \. ECOG-PS score: 0-1;
• \. Patients with normal function of organs such as heart, brain, lungs, and kidneys who can tolerate surgery;
• \. With a life expectancy of ≥ 6 weeks;
• \. Adequate major organ function without severe hematologic, cardiac, pulmonary, hepatic, renal, or bone marrow dysfunction, and no immunodeficiency disease;

You may not qualify if:

• \. Patients who have received or are currently receiving chemotherapy, radiotherapy, immunotherapy, or targeted therapy
• \. Patients with distant metastasis or inability to undergo resection after evaluation by thoracic surgeons
• \. Simultaneously developing tumors in other parts of the body
• \. Severe impairment of heart, liver, and kidney function (heart function grade 3-4, ALT and/or AST exceeding the upper limit of normal by more than 1.5 times, Cr (serum creatinine) exceeding the upper limit of normal by more than 1.5 times)
• \. Patients with a history of autoimmune diseases who were receiving immunosuppressive therapy prior to enrollment, with immunosuppressive doses\>10 mg/day or oral prednisone for more than 2 weeks
• \. Severe allergy to immune preparations
• \. Abnormal coagulation function: (PT\>16s, APTT\>53s, TT\>21s, Fib\<1.5 g/L), bleeding tendency or during thrombolytic or anticoagulant therapy
• \. Pregnancy or lactation period

Sponsors & Collaborators

• Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University: lead
• Jiangsu HengRui Medicine Co., Ltd.: collaborator

Study Sites (1)

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Guangzhou, Guangdong, China

RECRUITING

MeSH Terms

Conditions

Esophageal Squamous Cell Carcinoma

Interventions

130-nm albumin-bound paclitaxel; Carboplatin; Radiotherapy

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)

Coordination Complexes; Organic Chemicals; Therapeutics

Central Study Contacts

Baisheng Chen, M.D, PhD

CONTACT

+86-13560471611; Pason06213367@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: May 13, 2026
• First Posted: May 19, 2026
• Study Start: May 22, 2026
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): October 1, 2029
• Last Updated: May 19, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)