Esophageal Carcinoma
Conditions
Interventions
Experimental group:Immune maintenance with Tislelizumab
Sponsors
The First Affiliated Hospital of Bengbu Medical College
Eligibility
Sex/Gender
All
Age
70 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1)Histopathology confirmed patients with esophageal squamous cell carcinoma; 2) The clinical stage is cT1b-T4b, N0-N+, Patients who are deemed medically inoperable or refuse surgery through multidisciplinary team consultation by clinical doctors; 3) According to the RECIST 1.1 evaluation criteria for solid tumor efficacy, at least one measurable lesion must be present; Measurable lesions that have not received local treatment such as radiotherapy; 4) Patients aged 70-85, male or female; 5) ECOG PS score 0-1 points; Expected survival period >=6 months; 6) Having sufficient organ and bone marrow function, i.e. meeting the following criteria: (1) The blood routine examination standard meets: e) Hemoglobin content (HB) >= 90g/L (no blood transfusion within 28 days); f) Absolute neutrophil count (ANC) >= 1.5 × 109/L; g) Platelet count (PLT) >= 80 × 109/L; h) White blood cell count (WBC) >= 3.5 × 109/L; (2) Biochemical tests must meet the following standards: d) Serum total bilirubin (TBIL) =60ml/min (Cockcroft Gault formula); (3) Doppler ultrasound evaluation: Left ventricular ejection fraction (LVEF) >= lower limit of normal (50%); (4) Adequate coagulation function, defined as International Normalized Ratio (INR) or Prothrombin Time (PT) <=1.5 times ULN;
Exclusion criteria
Exclusion criteria: 1) Patients with active bleeding within 2 months, or those confirmed by biopsy to have invaded the trachea, bronchi, or tracheoesophageal fistula; 2) Individuals with multiple factors that affect oral drug absorption, such as post gastrointestinal resection, chronic diarrhea, and intestinal obstruction; 3) Having autoimmune diseases; 4) Patients with esophageal squamous cell carcinoma who have a tendency to bleed due to the placement of a stent in the esophageal duct, as determined by researchers; 5) Doctors assess patients who are at risk of esophageal fistula or bleeding; 6) Esophageal squamous cell carcinoma patients who cannot accept or tolerate oral chemotherapy drugs; 7) Patients who have undergone radiotherapy for the same part of the esophagus in the past; 8) Patients with any severe and/or uncontrolled illnesses, including: (1) Patients with poor blood pressure control (systolic blood pressure >=150 mmHg or diastolic blood pressure >= 100 mmHg); Suffering from grade I or above myocardial ischemia or infarction, arrhythmia (including QT interval >= 430ms), and grade I heart failure (New York Heart Association (NYHA) functional classification); (2) Active or uncontrolled severe infections; (3) Liver diseases such as cirrhosis, decompensated liver disease, and chronic active hepatitis; (4) Poor control of diabetes (FBG>10mmol/L); (5) Urine routine shows urinary protein >=++ and confirms 24-hour urinary protein quantification>1.0 g; 9) Long term untreated wounds or fractures; 10) Having undergone major surgical procedures (craniotomy, thoracotomy, or laparotomy) within 4 weeks prior to the first dose of the study or expecting to undergo major surgery during the study treatment period; 11) History of gastrointestinal perforation and/or fistula occurring within the 6 months prior to enrollment for treatment; Or those who have experienced arterial/venous thrombosis events, such as cerebrovascular accidents (including temporary ischemic attacks), deep vein thrombosis, and pulmonary embolism; 12) Patients whose imaging shows that the tumor has invaded important blood vessels or whose researchers have determined that the tumor is highly likely to invade important blood vessels and cause fatal massive bleeding during subsequent studies; 13) Ascites with clinical significance, including any ascites that can be detected during physical examination, ascites that has been treated in the past or still requires treatment, and only those with imaging showing a small amount of ascites but no symptoms can be selected; 14) Patients with equal amounts of fluid accumulation in both pleural cavities, or a large amount of fluid accumulation in one pleural cavity, or those who have caused respiratory dysfunction and require drainage; 15) Known to have active pulmonary tuberculosis; 16) Suffering from interstitial lung disease that requires steroid hormone therapy; 17) Uncontrolled metabolic disorders or other non malignant tumor organs or systemic diseases or secondary reactions to cancer, which can lead to higher medical risks and/or uncertainty in survival evaluation; 18) Significant malnutrition, such as the need for intravenous nutrient supplementation; Except for those who have had malnutrition corrected for more than 4 weeks before the first dose of study treatment; 19) Individuals with a history of abuse of psychotropic drugs who are unable to quit or have mental disorders; 20) Individuals with a history of immunodeficiency, including HIV positiv
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-Free Survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective Response Rate;Overall Survival;Disease Control Rate;Safety; | — |
Countries
China
Contacts
Public ContactLi Duojie
The First Affiliated Hospital of Bengbu Medical College
Outcome results
None listed