Adebrelimab Combined With Neoadjuvant Chemoradiotherapy for Esophageal Squamous Cell Carcinoma
Recruiting now · Phase 2
Conditions studied: Esophageal Squamous Cell Carcinoma (ESCC)
In brief
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.
Key facts
- Study ID
- NCT07595770
- Run by
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
- People needed
- 37
- Starts
- 2026-05-22
- Expected to finish
- 2029-10-01
- Last updated by the study team
- 2026-05-19
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- - 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;
You may not qualify if…
- 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.;
Where it is running
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University — Guangzhou, Guangdong, China (enrolling)
Full record on ClinicalTrials.gov
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