Esophageal squamouse cell carcinoma
Conditions
Interventions
Experimental group:All patients will receive 3 cycles of camrelizumab (260mg, on days 1), concurrently with 3 cycles of Albumin paclitaxel(Albumin paclitaxel 240mg/m2, on days 1) +S1(Tegafur, Gimeraci
60 mg per dose for BSA = 1.5 m2. Administration is on Days 1–14. The treatment consists of three cycles, on days 1-14). Esophagectomy is performed 6-8 weeks after neoadjuvant therapy completion
Sponsors
Sun Yat-sen University Cancer Center
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Age 18 to 75 years, male or female; 2.Histologically confirmed esophageal squamous cell carcinoma with positive cervical lymph node biopsy; 3.At least one metastatic cervical lymph node located above the clavicle and superior margin of the sternum; 4.Patients assessed by a multidisciplinary team (including thoracic surgery department, head and neck surgery department, and radiologists etc.) as having potentially resectable lesions, with no distant metastasis other than cervical lymph nodes, based on imaging and pathological findings; 5.Patients with at least one measurable lesion according to RECIST v1.1 criteria; 6.ECOG performance status score of 0-1. 7.Normal function of major organs (heart, brain, lung, kidney, etc.), and able to tolerate surgery. 8.Life expectancy of more than 6 months. 9.Patients who have signed the informed consent form.
Exclusion criteria
Exclusion criteria: 1.Patients who have received or are currently receiving chemotherapy, radiotherapy, immunotherapy, or targeted therapy. 2.Patients with distant metastasis other than cervical lymph nodes or deemed unresectable by thoracic surgeons; 3.Patients with a history of or concurrent malignancies at other sites; 4.Severe heart, liver, kidney diseases, including but not limited to the following:(> NYHA II congestive heart failure,ALT/AST>1.5ULN,Cr>1.5ULN); 5.Known or suspected allergy,usage of immunosuppressants before the enrollment, the amount of immunosuppressant used =10mg / day or oral prednisone for more than 2 weeks; 6.Patients who are HBsAg positive with detectable HBV DNA copies (quantitative detection =1000 cps/ml) or positive for HCVAb. 7.Patients with severe allergies; 8.Abnormal blood coagulation function (PT>16s, APTT>53s, TT>21s, Fib<1.5g/L), bleeding tendency or receiving thrombolysis or anticoagulant therapy; 9.Pregnant or breastfeeding women; 10.Other situations evaluated by investigators not meet the enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1 year disease-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pathological Complete Response;Major Pathological Response;negative conversion rate of cervical lymph nodes;1 year overall survival;3 year overall survival;3 year disease-free survival; | — |
Countries
China
Contacts
Public ContactXu Zhang
Sun Yat-sen University Cancer Center
Outcome results
None listed