esophageal squamous cell cancer
Conditions
Interventions
Experimental group:Neoadjuvant low dose radiotherapy (30Gy/15f) combined with PD-1 inhibitor (sindilizumab) and chemotherapy used as neoadjuvant therapy
Experimental group:Neoadjuvant low dose radiotherapy (40Gy/20f) combined with PD-1 inhibitor (sindilizumab) and chemotherapy used as neoadjuvant therapy
Sponsors
West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Histologically (pathologically) confirmed esophageal squamous cell carcinoma with clinical stage: cT1-3,N+,M0 (AJCC/UICC stage of esophageal carcinoma (8th)); 2.R0 radical resection can be performed; 3.Eastern Cooperative Oncology Group (ECOG) physical status score was 0 or 1; 4.At the time of screening, the age of male or female subjects aged >=18 years old,and 80%.) 9.Liver function: serum total bilirubin (TBIL) = 1.5 times the upper limit of normal (ULN), alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) = 2.5 times the ULN, serum albumin (ALB) = 3 g/dL 10.Renal function: serum creatinine = 1.5 × ULN, or creatinine clearance = 60ml/min (calculated by Cockcroft/Gault formula); 11.willing to participate in the study and sign the written informed consent form, and can comply with the visits and related procedures specified in the protocol; 12.Life expectancy>6 months; 13.Radiotherapy physicians judge no radiotherapy contraindication patients; 14.Patients who agree to receive surgery, chemotherapy and immunotherapy; 15.Women of childbearing potential must have been pregnant and negative within 7 days prior to the start of treatment; All subjects, regardless of gender, should be willing to use an appropriate method of contraception during the trial and for 8 weeks after the last dose of trial medication. 16.No esophageal perforation and active esophageal bleeding, no trachea, thoracic vascular invasion; 17.At least one radiologically measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST version 1.1).
Exclusion criteria
Exclusion criteria: 1.Not suitable for receiving any double-agent chemotherapy specified in the protocol; 2.Prior treatment for ESCC, including investigational drugs, chemotherapy, radiotherapy, or prior treatment with anti-PD-1, anti-PD-L1, anti-PD-L2, or any other antibody or drug specifically targeting the T cell costimulatory checkpoint pathway; 3.History of fistula due to primary tumor invasion; 4.Patients with high risk of fistula or evidence of perforation as assessed by the investigator; 5.Any condition requiring systemic treatment with corticosteroids (prednisone> _10 mg/day or equivalent dose of similar drugs) or other immunosuppressive agents within 14 days prior to the first dose; 6. Adrenaline replacement steroids (prednisone =_1_0_ _mg/day or equivalent dose of drugs in the same class) and topical, ophthalmic, intra-articular, intranasal and inhaled corticosteroids with minimal systemic absorption, as well as short-term (=_7_days) use of corticosteroids for prevention or treatment of non-autoimmune conditions are allowed;(Paclitaxel pretreatment with dexamethasone may be used). 7.Subjects with active autoimmune disease or a history of autoimmune disease that is likely to recur; 8. Subjects may be enrolled in the study if: well-controlled type I diabetes mellitus, hypothyroidism requiring hormone replacement therapy only, well-controlled celiac disease, skin conditions that do not require systemic treatment (e.g. vitiligo, psoriasis or alopecia) or conditions that do not recur in the absence of external triggers; 9.History of interstitial lung disease, pneumonitis, or poorly controlled lung disease (including pulmonary fibrosis, acute lung disease, etc.); 10.Infections requiring systemic antibacterial, antifungal, or antiviral treatment, including tuberculosis infections 11. Severe infection within 4 weeks prior to the first dose, including but not limited to infectious complications leading to hospitalization, bacteremia, or severe pneumonia 12. Treatment with oral or intravenous antibiotics within 2 weeks prior to the first dose 13.Known allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation; 14.Patients with Known allergic reaction to the active ingredients or excipients of the investigational drug, sindilitumumab, and combination chemotherapy drugs.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| pathological complete response rate;safety; | — |
Secondary
| Measure | Time frame |
|---|---|
| R0 resection rate;Objective response rate;1year disease free survival rate;3year disease free survival rate; | — |
Countries
China
Contacts
Public ContactLiu Yongmei
West China Hospital of Sichuan University
Outcome results
None listed