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Adebrelimab Combined With Neoadjuvant Chemoradiotherapy for Esophageal Squamous Cell Carcinoma
RECRUITINGPhase 2Sponsored by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Actively Recruiting
PhasePhase 2
SponsorSun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Started2026-05-22
Est. completion2028-01-01
Eligibility
Age18 Years – 75 Years
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT07595770
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
Age: 18 Years – 75 YearsHealthy volunteers accepted
Inclusion Criteria: * \- 1. Provided informed consent and sign the informed consent form; * 2\. Male or female, Aged 18-75 years (counted on the date of signing informed consent); * 3\. Pathological confirmed ESCC; * 4\. Patients assessed by thoracic oncologists as resectable without distant metastasis * 5\. Patients evaluate with clinical staging of T1-4aN1-3M0 or T3-4aN0M0(AJCC 9.0) based on imaging and pathological examination results; * 6\. Have at least one assessable lesion according to the RECIST V1.1 * 7\. ECOG-PS score: 0-1; * 8\. Patients with normal function of organs such as heart, brain, lungs, and kidneys who can tolerate surgery; * 9\. With a life expectancy of ≥ 6 weeks; * 10\. Adequate major organ function without severe hematologic, cardiac, pulmonary, hepatic, renal, or bone marrow dysfunction, and no immunodeficiency disease; Exclusion Criteria: * 1\. Patients who have received or are currently receiving chemotherapy, radiotherapy, immunotherapy, or targeted therapy * 2\. Patients with distant metastasis or inability to undergo resection after evaluation by thoracic surgeons * 3\. Simultaneously developing tumors in other parts of the body * 4\. 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) * 5\. 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 * 6\. Severe allergy to immune preparations * 7\. Abnormal coagulation function: (PT\>16s, APTT\>53s, TT\>21s, Fib\<1.5 g/L), bleeding tendency or during thrombolytic or anticoagulant therapy * 8\. Pregnancy or lactation period * 9\. Other situations as judged by investigators not suitable for inclusion.;
Conditions2
CancerEsophageal Squamous Cell Carcinoma (ESCC)
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Actively Recruiting
PhasePhase 2
SponsorSun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Started2026-05-22
Est. completion2028-01-01
Eligibility
Age18 Years – 75 Years
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT07595770