esophageal cancer
Conditions
Interventions
A:Adebrelimab: intravenous drip, fixed dose of 1200 mg, d1, q3w
Cis-platin: 50mg/m2 intravenous drip, d1 (which can be divided into 1-3 days), q3w
Paclitaxel for Injection(Albumin Bound): 110mg/m2 -125mg/m2 (according to the patients physical condition), administered by intravenous drip, d1, d8, q3w
B:Cis-platin: 50mg/m2 intravenous drip, d1 (which can be divided into 1-3 days), q3w
C:Adebrelimab: intravenous drip, fixed dose of 1200 mg, d1, q3w
Sponsors
Cancer Hospital of China Academy of Medical Sciences
Eligibility
Sex/Gender
All
Age
75 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. Age =75 years old, regardless of sex; 2. Esophageal squamous cell carcinoma diagnosed by pathology (except for inoperable tumors in the neck and chest); 3. Patients with resectable esophageal squamous cell carcinoma with clinical stage T2-T4aN0-2M0; 4. At least one measurable lesion (according to RECIST1.1 standard) or an unmeasurable lesion that can be evaluated; 5. No previous anti-tumor treatment, including surgery, chemotherapy, radiotherapy and targeted immunotherapy; 6. The score of 6.ECOG-PS is 0-1; 7. The estimated survival time is =3 months; 8. The main organs function normally, and there are no serious abnormal functions of blood, heart, lung, liver, kidney, bone marrow and immune deficiency diseases. Laboratory inspection shall meet the following requirements: A. hemoglobin (HB) = 90g/l; B. White blood cell (WBC) =3.5×10^9/L;/L; Neutrophil count (NEUT)= 1.5×10^9/L;/L; C. platelet count (PLT) = 90× 10^9/l; D. Serum creatinine (SCr) = 1.5×ULN or creatinine clearance =50 ml/min(Cockcroft-Gault formula); E. total bilirubin (TBIL)= 1.5×ULN;; F the level of aspartate aminotransferase (AST) or alanine aminotransferase (ALT) is = 2.5× ULN;; If there is liver metastasis, it can be = 5×ULN;; G. urinary protein < 2+; If the urine protein is =2+, the 24-hour urine protein quantitative display protein must be = 1g; Coagulation function is normal, and there is no active bleeding or thrombotic disease; A. the international standardized ratio INR = 1.5× ULN; B. partial thromboplastin time APTT=1.5×ULN;; C. prothrombin time PT=1.5×ULN;; 9. Non-surgical sterilization or female subjects of childbearing age need to adopt a medically recognized contraceptive measure (such as intrauterine device, contraceptive or condom) during the research treatment and within 180 days after the end of the research treatment; The serum HCG test of non-surgically sterilized female subjects of childbearing age must be negative within 72 hours before randomization; And must be non-lactating; For male subjects whose partners are women of childbearing age, effective contraceptive methods should be adopted during the study treatment period and within 180 days after the end of the study treatment period. 10. Subjects voluntarily participate in this study, fully understand and know this study, and sign an informed consent form (ICF); 11. Those who expect good compliance can follow up the curative effect and adverse reactions according to the requirements of the plan;
Exclusion criteria
Exclusion criteria: 1. It has been diagnosed as other malignant tumors within 5 years before the first use of the study drug, except for effectively treated basal cell carcinoma of skin, squamous cell carcinoma of skin and/or effectively resected in situ cervical cancer and/or breast cancer; 2. Suffering from any active autoimmune disease or autoimmune disease history (such as interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, myocarditis, nephritis, hyperthyroidism and hypothyroidism (except for patients with stable hormone level after treatment); Patients with childhood asthma who have been completely relieved and do not need any intervention or vitiligo after adulthood can be included, but subjects who need medical intervention with bronchodilators can not be included; 3. Suffering from congenital or acquired immunodeficiency, such as human immunodeficiency virus (HIV) infection, active hepatitis B (HBV DNA = 500 IU/ml), hepatitis C (HCV antibody positive, and HCV-RNA higher than the detection limit of the analysis method) or co-infection of hepatitis B and hepatitis C; 4. Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation; 5. Immunosuppressive drugs have been used within 14 days before the first use of the study drug, excluding nasal spray and inhaled corticosteroids or systemic steroid hormones with physiological dose (that is, no more than 10 mg/ day of prednisolone or other corticosteroids with the same drug physiological dose); 6. Vaccinate live vaccine within 4 weeks before the first administration or during the study period; 7. Suffering from uncontrollable cardiac clinical symptoms or diseases, such as (1) heart failure of 1)NYHA II or above (2) unstable angina pectoris (3) myocardial infarction within one year (4) poorly controlled arrhythmia; 8. Those who are known to have allergic history to the drug components of this scheme; 9. There are risks that may increase participation in research and drug use, or other severe, acute and chronic diseases; 10. Received major surgery within 4 weeks before the first administration; 11. Other circumstances that the researcher thinks are not suitable for inclusion.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Event free survival;R0 resection rate;Main pathological remission rate;Total survival time; | — |
Primary
| Measure | Time frame |
|---|---|
| Pathological complete remission rate; | — |
Countries
China
Contacts
Public ContactLi Yong
Cancer Hospital of China Academy of Medical Sciences
Outcome results
None listed