Esophageal cancer
Conditions
Interventions
Single arm:Cardonizumab: 6mg/kg intravenous drip d1 q3w
Albumin bound paclitaxel: 260mg/m2 q3w, four cycles
Nedaplatin: 80mg/m2 iv d1 q3w four cycles.
Sponsors
Tianjin Cancer Hospital Airport Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1) Sign a written informed consent form before joining the group; 2) Age 18-70 years old, both male and female; 3) T4N0-3M0, T1-4N2-3M0, and T1-4N1-3M1 in patients with locally advanced, metastatic, or recurrent esophageal squamous cell carcinoma confirmed by pathology and imaging (AJCC/UICC Eighth Edition TNM staging of esophageal cancer); If the subject received adjuvant treatment after completing the radical Sex therapy and the disease recurred, it is necessary to ensure that the interval between the end of adjuvant treatment and the first administration of this study is more than 6 months 4) Evaluate patients with non surgical resection of esophageal cancer before treatment; 5) ECOG PS score: 0-1; 6) The expected survival period is greater than 6 months; 7) The function of important organs meets the following requirements (excluding the use of any blood components and cell growth factors within 14 days): • Blood routine: -Neutrophils = 1.5 * 109/L -Platelet count = 100 * 109/L -Hemoglobin = 90g/L; • Liver and kidney function: -Serum creatinine (SCr) = 1.5 times the upper limit of normal value (ULN) or creatinine clearance rate = 50 ml/min (Cockcroft Fault formula); -Total bilirubin (TBIL) = 1.5 times the upper limit of normal value (ULN); -The level of aspartate Transaminase (AST) or Alanine transaminase (ALT) = 2.5 times the upper limit of normal (ULN); Urinary protein<2+; If the urine protein is = 2+, the 24-hour urine protein quantitative display must be = 1g; 8) Normal coagulation function, no active bleeding or thrombosis disease a. International standardized ratio INR = 1.5 × ULN; b. Partial thromboplastin time APTT = 1.5 × ULN; c. Prothrombin time PT = 1.5ULN; 9) Non operative sterilization or female patients of childbearing age need to use a medically approved contraceptive measure (such as Intrauterine device, pill or condom) during the study treatment period and within 3 months after the end of the study treatment period; Non surgically sterilized female patients of childbearing age must have a negative serum or urine HCG test within 7 days before enrollment in the study; And it must be non lactating; Non surgical sterilization or male patients of childbearing age are required to agree to use a medically approved contraceptive method with their spouse during the study treatment period and within 3 months after the end of the study treatment period. 10) The subjects voluntarily joined this study with good compliance, safety, and survival follow-up.
Exclusion criteria
Exclusion criteria: 1) Subjects had other malignant tumors before or at the same time (except cured skin Basal-cell carcinoma and cervical Carcinoma in situ); 2) Previously received treatment with cardunizumab or other PD-1/PD-L1; The subject is known to have previous allergies to macromolecular protein formulations, or to any Cardunizumab, albumin bound paclitaxel, or platinum based components; 3) The subject has any active autoimmune disease or a history of autoimmune disease (For example, but not limited to: Autoimmune hepatitis, interstitial pneumonia, Uveitis, enteritis, hepatitis, hypophysitis, Vasculitis, nephritis, hyperthyroidism, hypothyroidism; subjects suffering from Vitiligo or asthma in childhood has been completely alleviated and do not need any intervention after adulthood can be included; subjects who need Bronchiectasis for medical intervention cannot be included in asthma 4) The subject is using Immunosuppressive drug, or systemic or absorbable local hormone treatment to achieve immunosuppression (Dose>10mg/day of prednisone or other therapeutic hormones) and continued to be used within 2 weeks before enrollment; 5) Therapeutic puncture or drainage is required for ascites or Pleural effusion with clinical symptoms; 6) Patients with clinically uncontrollable cardiac symptoms or diseases, such as: (1) NYHA grade 2 or above heart failure, (2) unstable angina pectoris, (3) myocardial infarction within 1 year, (4) clinically significant supraventricular or ventricular arrhythmias that require treatment or intervention; 7) Abnormal coagulation function (PT>16s, APTT>43s, TT>21s, Fbg>2g/L), with bleeding tendency or undergoing thrombolytic or anticoagulant treatment; 8) At present (within 3 months), the patient has digestive tract diseases such as esophageal varices, gastric and duodenal active ulcers, Ulcerative colitis, Portal hypertension, or other conditions that may cause gastrointestinal bleeding and perforation as determined by the researcher; 9) Thromboembolic events (including stroke events and/or Transient ischemic attack) occurred within 12 months; 10) The subject has an active infection or an unexplained fever>38.5 degrees Celsius during the screening period or before the first administration (according to the researcher's judgment, the subject's fever caused by the tumor can be included in the group); 11) Less than 4 weeks before the study medication, there were abdominal fistulas, gastrointestinal perforation, or abdominal abscesses; 12) Patients with past and current objective evidence of Pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonia, drug-related pneumonia, and serious impairment of lung function; 13) Subjects have congenital or acquired immune deficiency, such as HIV infected persons, or active hepatitis (Transaminase does not meet the inclusion criteria, hepatitis B reference: HBV DNA = 1000 IU/ml; hepatitis C reference: HCV RNA = 103 IU/ml); Chronic hepatitis B virus carriers with HBV DNA<2000 IU/ml must receive antiviral treatment simultaneously during the trial period before they can be enrolled; 14) The subject is currently participating in other clinical studies or less than one month after the completion of the previous clinical study; Subjects may receive other systemic anti-tumor treatments during the study period; 15) Live vaccines may be administered less than 4 weeks before the study medication or during the study period; 16) The subject is known to have a history of abuse of psycho
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progressive free survival time;Overall survival time;Disease control rate;Duration of disease relief;Safety; | — |
Countries
China
Contacts
Public ContactZhanyu Pan
Tianjin Cancer Hospital Airport Hospital
Outcome results
None listed