Esophageal Squamous Cell Carcinoma
Conditions
Interventions
Experimental group:Camrelizumab (SHR-1210): Administered by intravenous infusion at a fixed dose of 200 mg, on Day 1, repeated once every 3 weeks
Albumin-bound paclitaxel: 260 mg/m2, intravenous infusion, on Day 1, repeated once every 3 weeks
Cisplatin: 60 mg/m2, intravenous infusion, on Day 1, repeated once every 3 weeks.
Control group:Albumin-bound paclitaxel: 260 mg/m2, intravenous infusion, on Day 1, repeated once every 3 weeks
Sponsors
The First Affiliated Hospital of Anhui Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 75 years; 2. Patients with resectable esophageal squamous cell carcinoma diagnosed by histopathology or cytology (cT1-4N1-3M0 and cT3-4N0M0 patients); 3. No previous treatment, including surgery, chemotherapy, radiotherapy, immunotherapy and targeted therapy; 4. ECOG PS score 0-1 points; 5. Estimated survival time >= 3 months; 6. The main organ functions are normal, and there are no patients with severe blood, heart, lung, liver, kidney, bone marrow and other functional abnormalities and immunodeficiency. The laboratory inspection meets the following requirements: (1) Hemoglobin (Hb) >=90 g/L; (2) White blood cell (WBC)>=3.0x10^9/L; Neutrophil count (NEUT)>=1.5x10^9/L; (3) Platelets (PLT) >=100x10^9/L; (4) Liver function (aspartate aminotransferase AST or alanine aminotransferase ALT) level <=2.5 ULN; renal function (serum creatinine sCr) level <=1.5 ULN; (5) Total bilirubin (TBIL) <=1.5 ULN; (6) Urine protein, urine occult blood <2+; fecal occult blood <2+; 7. Subjects voluntarily join the study, sign an informed consent form, have good compliance, and cooperate with follow-up; 8. Researchers believe that treatment can benefit.
Exclusion criteria
Exclusion criteria: 1. Those who have been confirmed to be allergic to the test drug and/or its excipients; 2. Subjects who have received or are receiving additional chemotherapy, radiotherapy, targeted or immunotherapy; 3. Suffer from any active autoimmune diseases or history of autoimmune diseases; subjects with childhood asthma that have been completely relieved and do not require any intervention or vitiligo after adulthood can be included, and subjects who require medical intervention with bronchodilators cannot be included; 4. Suffer from congenital or acquired immune function defects, such as human immunodeficiency virus (HIV) infection, active hepatitis B (HBV DNA >=500 IU/mL), hepatitis C (hepatitis C antibody positive, and high HCV-RNA Under the detection limit of the analytical method) or co-infection with hepatitis B and C; or a history of organ transplantation; 5. There are clinical symptoms or diseases of the heart that are not well controlled, such as: (1) Heart failure above NYHA level 2; (2) Unstable angina; (3) Myocardial infarction occurred within 1 year; 6. Pregnant or lactating women; 7. According to the judgement of the investigator, patients who are not suitable for inclusion in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| pathological complete response rate;event-free survival;Incidence of adverse reactions,; | — |
Secondary
| Measure | Time frame |
|---|---|
| objective response rate;disease free survival;overall survival; | — |
Countries
China
Contacts
Public ContactRenquan Zhang
The First Affiliated Hospital of Anhui Medical University
Outcome results
None listed