Stage II-IVA esophageal squamous cell carcinoma confirmed by pathological histology or cytology
Conditions
Interventions
Selective Lymph Node Dissection Group:Esophagectomy (McKeown) + Selective Lymph Node Dissection
Neoadjuvant Therapy: Toripalimab 240mg IV D1 Q3W + Carboplatin AUC=5 IV D1 Q3W + Albumin-bound Paclitaxel 260mg/m2 IV D1 Q3W
Systematic Lymph Node Dissection Group:Esophagectomy (McKeown) + Systematic Lymph Node Dissection
Sponsors
The First Affiliated Hospital,Sun Yat-sen University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Patients with resectable locally advanced squamous cell carcinoma of the thoracic esophagus or esophagogastric junction, classified as clinical stage cT1N2M0 or cT2-3/N0-2/M0 (Stage II-III) according to the 8th edition UICC staging system prior to treatment. 2. Treatment-naïve patients who have not received any prior anti-tumor therapy. 3. Expected survival time greater than 6 months. 4. Age 18–70 years. 5. Adequate organ and bone marrow function, defined as follows: (1) Hematology: Absolute neutrophil count (ANC) >=1.5×10^9/L; platelet count (PLT) >=80×10^9/L; hemoglobin (HGB) >=8.0 g/dL. (2) Liver function: Total bilirubin (TBIL) =30 mL/min (calculated using the Cockcroft-Gault formula). Adequate coagulation function, defined as international normalized ratio (INR) or prothrombin time (PT) <=1.5 × ULN; for subjects receiving anticoagulant therapy, PT must be within the therapeutic range intended for the anticoagulant. 6. WHO performance status (PS) score 0–1. 7. Ability to understand the study and provide signed informed consent.
Exclusion criteria
Exclusion criteria: 1. Patients who have previously received anti-tumor therapy (including chemotherapy, radiotherapy, and surgery); 2. Known hypersensitivity to any monoclonal antibody or chemotherapy agents (paclitaxel, carboplatin) formulations or excipients; 3. Patients with existing or concurrent bleeding disorders; 4. Other patients with uncontrolled conditions rendering them inoperable; 5. Women who are pregnant or breastfeeding; 6. Patients unable to provide informed consent due to psychological, family, or social factors; 7. Patients with peripheral neuropathy, CTC grade >=2; 8. Patients with a history of other malignancies prior to enrollment, excluding non-melanoma skin cancer, cervical carcinoma in situ, or cured early-stage prostate cancer, in addition to esophageal cancer; 9. Patients with a history of diabetes for more than 10 years and unsatisfactory blood glucose control; 10. Patients with severe cardiac, pulmonary, hepatic, or renal insufficiency, hematopoietic system diseases, immune system diseases, cachexia, or other conditions intolerant to radiotherapy, chemotherapy, or surgery.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease-Free Survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival;3-Year and 5-Year Survival Rate;Incidence of Perioperative Complications;Quality of Life;R0 Resection Rate;Perioperative Mortality Rate; | — |
Countries
China
Contacts
Public ContactCheng Chao
The First Affiliated Hospital,Sun Yat-sen University
Outcome results
None listed