Esophageal squamouse cell carcinoma
Conditions
Interventions
Experimental group:All patients will receive 3 cycles of camrelizumab (200mg, 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
70 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Aged >= 70 years, male or female. 2.Histologically confirmed thoracic esophageal squamous cell carcinoma. 3.No distant metastasis as indicated by imaging evidence. 4.Patients who are resectable based on imaging evidence and performance status. 5.Patients with clinical stage III-IVA according to the 8th edition of the AJCC staging system. 6.Patients with at least one measurable lesion according to RECIST v1.1 criteria. 7.ECOG performance status score of 0-1. 8.Normal function of major organs (heart, brain, lung, kidney, etc.), and able to tolerate surgery. 9.Life expectancy of more than 6 months. 10.Patients who have signed the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Patients who have received or are receiving chemotherapy, radiotherapy, immunotherapy or targeted therapy; 2. Patients with distant metastasis or unresectable after evaluation by thoracic surgeons; 3. Concurrent tumors in other parts; 4. Severe impairment of heart, liver and kidney function (grade 3 to 4 of heart function, ALT and/or AST exceeding 1.5 times of upper limit of normal, Cr exceeding 1.5 times of upper limit of normal); 5. Patients with a history of autoimmune diseases who were receiving immunosuppressive therapy with a dose of >10mg/ day or oral prednisone for more than 2 weeks before enrollment; 6. Both HBsAg positive and HBV DNA copy number positive (quantitative detection ?1000cps/ml) or HCV antibody positive; 7. Severe allergies; 8. Abnormal coagulation function (PT>16s, APTT>53s, TT>21s, Fib<1.5g/L), bleeding tendency or thrombolytic or anticoagulant therapy; 9. Other conditions considered by the investigator to be unsuitable for enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1 year event-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pathological Complete Response;Major Pathological Response;1 year overall survival;1 year disease-free survival; | — |
Countries
China
Contacts
Public ContactXu Zhang
Sun Yat-sen University Cancer Center
Outcome results
None listed