Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Phase
Phase 2
Started
2026-05-22
Last updated
2026-05-19
Condition(s) studied
Esophageal Squamous Cell Carcinoma (ESCC)
Investigational drug(s) / intervention(s)
• Adebrelimab and nab-paclitaxel, carboplatin in Combination With radiotherapy
• Adebrelimab and nab-paclitaxel, carboplatin in Combination With radiotherapy: 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.
Study 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
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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.;
Primary outcome measure(s)
Pathological complete response (pCR) — From patient enrollment to the end of surgery 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).
Trial sites (1)
Facility
City
Region
Status
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Guangzhou
Guangdong
Recruiting
More Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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