Esophageal squamous cell cancer
Conditions
Interventions
Experimental group:Carrellizumab combined with chemotherapy
Sponsors
West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 75 years, no gender limit; 2. ECOG PS: 0-1; 3. Pathologically confirmed esophageal squamous cell carcinoma with measurable tumor focus (spiral CT scan >=10mm, meeting mRECIST1.1 standard); 4. According to the eighth edition of clinical tumor TNM staging, the clinical staging determined by CT is locally advanced (cT2-4N0-2M0), which is not suitable for endoscopic stripping or resection, and there is no distant metastasis; 5. The function of vital organs meets the following requirements (no blood components and cell growth factors are allowed to be used 2 weeks before the start of research and treatment): (1) Routine blood examination must meet: 1) Absolute neutrophil count (ANC) >= 1.5x10^9/L; 2) Hemoglobin (HB) >=9g/dL; 3) Platelets (PLT) >=100x10^9/L; 4) Serum albumin (ALB) >=2.8g/dL. (2) The biochemical inspection must meet: 1) Total bilirubin (TBIL)=50ml/min (Cockcroft-Gault formula); 4) The thyroid function is normal. 6. The expected survival period is >=3 months; 7. The investigator determined that the patient can receive carrellizumab treatment; 8. Fertile female subjects should have a urine or serum pregnancy test that proves negative within 72 hours prior to receiving the initial study drug administration and be willing to use an effective method of contraception during the study period until 3 months after the last dose of carrellizumab; For male subjects whose partners are women of reproductive age, effective contraception should be used during the trial and for 3 months after the last dose of carrellizumab; 9. The patient voluntarily joined the study and signed an informed consent (ICF), with good compliance and cooperation with follow-up.
Exclusion criteria
Exclusion criteria: 1. Esophageal adenocarcinoma or mixed adenocarcinoma, small cell carcinoma components; 2. Merge other tumors; 3. Suffer from any active autoimmune disease or have a history of autoimmune disease, such as interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism (hormonal Can be included after replacement therapy is normal); 4. Suffer from cachexia; 5. The liver and kidneys and other organs are seriously inadequate to receive chemotherapy; 6. Suffer from congenital or acquired immune deficiency (such as HIV infection), active hepatitis B (HBV-DNA >=104 copies/mL) or hepatitis C (hepatitis C antibody positive, and HCV-RNA is higher than the lower limit of the analysis method) 7. Known to be allergic to macromolecular protein preparations, or to any carrellizumab component; 8. Patients with severe allergic reaction to paclitaxel or intolerance to platinum; 9. Subjects who are required to use corticosteroids (>10mg/day, prednisone curative dose) or other immunosuppressive agents for systemic treatment within 14 days before the first use of the study drug; in the absence of active autoimmune diseases, Allow inhalation or topical use of steroids and the replacement of adrenal cortex hormones with a dose> 10 mg/day, prednisone therapeutic dose of adrenocortical hormone replacement; 10. As judged by the investigator, the subject may have other factors that may lead to the termination of the study, such as other serious diseases (including mental diseases) requiring combined treatment, serious abnormal laboratory test values, family or social factors, and difficult long-term follow-up; 11. Other circumstances judged by the investigator to be unsuitable for inclusion in this study; 12. The patient has received anti-tumor therapy in the past.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse event; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate;Pathological complete response;Surgical completion rate;Incidence of surgery-related adverse events 4 weeks after surgery;Progression free survival rate at 24 weeks after surgical treatment;Progression free survival;Overall survival; | — |
Countries
China
Contacts
Public ContactDing ZhenYu
West China Hospital, Sichuan University
Outcome results
None listed