Adebrelimab Combined With Neoadjuvant Chemoradiotherapy for Esophageal Squamous Cell Carcinoma
A Study on the Safety and Efficacy of Adalimumab Combined With Chemoradiotherapy as Neoadjuvant Therapy for Esophageal Squamous Cell Carcinoma
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
37 participants
May 22, 2026
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria10
- \- 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;
Exclusion Criteria9
- \. 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
- \. Other situations as judged by investigators not suitable for inclusion.;
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Interventions
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.
Locations(1)
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NCT07595770