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.
- 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
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)
Single group
• Adebrelimab and nab-paclitaxel, carboplatin in Combination With radiotherapy
DrugPatients 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.
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).
R0 resection rate
The proportion of patients with tumor margins showing no residual cancer cells under the microscope after surgical resection. That is, the proportion of patients in PPS achieving R0 resection.
Disease free survival (DFS)
Disease free survival (DFS) refers to the time from the start of treatment until disease recurrence or death from any cause, whichever occurs first.
Overall survival (OS)
OS is the time interval from the start of treatment to death due to any reason or loss of follow-up
Major pathological remission (MPR)
Major pathological remission (MPR) refers to the percentage of residual tumor cells in the tumor bed after neoadjuvant therapy being ≤ 10%, regardless of whether there are residual tumor cells in the lymph nodes.
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Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Lead sponsor
Jiangsu HengRui Medicine Co., Ltd.
Collaborator
