Esophageal squamous cell carcinoma
Conditions
Interventions
experimental group A:Preoperative concurrent chemotherapy with albumin paclitaxel, cisplatin and cindilizumab
experimental group B:Preoperative neoadjuvant chemotherapy with albumin, paclitaxel and cisplatin
Sponsors
Harbin Medical University Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Resectable locally advanced esophageal squamous cell carcinoma (clinical stage iia-iiib); 2. Aged 18 to 70 years, male or female; 3. There are measurable and evaluable lesions in accordance with RECIST 1.1; 4. No anti-tumor therapy, including chemotherapy and local treatment, was given before operation; 5. ECoG PS: 0-1; 6. The functions of important organs meet the following requirements: (1) Absolute neutrophil count >= 1.5 x 10^9/L Platelets >= 100 x 10^9/L Hemoglobin >= 9g / dl; 8 g / dl; (2) Thyroid stimulating hormone (TSH) <= 1 fold ULN (if abnormal, T3 and T4 levels should be examined at the same time, if T3 and T4 levels are normal, they can be included in the group); (3) Bilirubin <= 1.5 fold ULN; ALT and AST <= 5 fold ULN; (4) Serum creatinine <= 1.5 fold ULN. 7. The expected survival time is more than 3 months; 8. Non surgical sterilization or female patients of childbearing age need to use a medically approved contraceptive method during the study treatment period and within 3 months after the end of the study treatment period; The serum or urine HCG test must be negative within 72 hours before the study; And it must be non lactation period; For men, surgical sterilization should be adopted, or appropriate contraceptive methods should be adopted during the trial period and within 3 months after the last administration of the trial drug; 9. The patients voluntarily joined the study and signed the informed consent (ICF), with good compliance and follow-up.
Exclusion criteria
Exclusion criteria: 1. Previous or concurrent with other malignant tumors, except for fully treated non melanoma skin cancer, cervical carcinoma in situ and papillary thyroid cancer; 2. Active hepatitis B or C (hepatitis B: HBsAg positive and HBV-DNA >= 10 copies / ml; Hepatitis C: HCV antibody and HCV-RNA are positive, and antiviral therapy is needed at the same time); 3. Active tuberculosis infection. Patients with active tuberculosis infection within one year before medication should be excluded even if they have been treated; Patients with a history of active tuberculosis infection more than one year ago should also be excluded, unless it is proved that they have received standard anti tuberculosis treatment before; 4. Have active, known or suspected autoimmune diseases (including but not limited to: uveitis, enteritis, hepatitis, hypophysitis, nephritis, vasculitis, hyperthyroidism, hypothyroidism and asthma requiring bronchodilator treatment). Subjects with hypothyroidism who only need hormone replacement therapy and skin diseases (such as vitiligo, psoriasis or alopecia) who do not need systemic therapy can be selected; 5. Previous interstitial lung disease or (non infective) pneumonia and need oral or intravenous steroid therapy; 6. Heart diseases that are not well controlled, such as: (1) New York Heart Association (NYHA) grade 2 or above heart failure; (2) Unstable angina pectoris; (3) Myocardial infarction occurred within 1 year; (4) Supraventricular or ventricular arrhythmias with clinical significance and requiring treatment or intervention. 7. It is known that the subjects have been allergic to macromolecular protein preparations or any components of sindilimab; 8. Human immunodeficiency virus (HIV, HIV 1 / 2 antibody) positive; 9. Live vaccine was inoculated or will be inoculated within 30 days before the administration of sindilizumab; 10. A history of psychotropic drug abuse, alcoholism or drug abuse; 11. Other factors that may affect the safety of the subjects or the compliance of the test were judged by the researchers. For example, serious diseases (including mental illness), serious laboratory abnormalities or other family or social factors that need to be treated together.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathological partial remission rate; | — |
Countries
China
Contacts
Public ContactMa Jianqun
Harbin Medical University Cancer Hospital
Outcome results
None listed