esophageal cancer
Conditions
Interventions
Test group:Sindilimumab combined with radiotherapy
Sponsors
Anhui Provincial Cancer Hospital
Eligibility
Sex/Gender
All
Age
70 Years to No maximum
Inclusion criteria
Inclusion criteria: Patients eligible for this study must meet all of the following criteria: 1. Sign written informed consent before implementing any experimental procedures; 2. Male or female, aged >= 70 years old; 3. Histopathology confirmed as locally advanced esophageal squamous cell carcinoma, diagnosed as cT1b-4bN0M0/cT1-4bN+M0 based on endoscopic ultrasound or enhanced CT/MRI scan cTNM; 4. Evaluated by researchers as unsuitable for radical surgery and radical radiotherapy and chemotherapy; According to the criteria for evaluating the efficacy of solid tumors (RECIST version 1.1), there should be at least one measurable lesion on imaging; 6. No previous surgical treatment, no anti-tumor radiotherapy/chemotherapy/immunotherapy; 7. ECOG score 0-1 points; 8. Expected survival time >= 3 months; 9. Adequate organ function, subjects must meet the following laboratory indicators: 1) In the past 14 days without using granulocyte colony-stimulating factor, the absolute neutrophil count (ANC) was >= 1.5x10^9/L. 2) Platelets >=100 × 10^9/L without blood transfusion in the past 14 days. 3) Hemoglobin>9g/dL in the past 14 days without blood transfusion or use of erythropoietin; 4) Total bilirubin ULN but direct bilirubin <= ULN 5) Aspartate transaminase (AST) and alanine transaminase (ALT) levels are <= 2.5 × ULN 6) Blood creatinine <= 1.5 × ULN and creatinine clearance rate (calculated using Cockcroft Gault formula) = 60 ml/min; 7) Good coagulation function, defined as International Normalized Ratio (INR) or Prothrombin Time (PT) <= 1.5 times ULN; 8) Normal thyroid function is defined as thyroid stimulating hormone (TSH) within the normal range. If the baseline TSH exceeds the normal range, subjects with total T3 (or FT3) and FT4 within the normal range can also be enrolled; 9) The myocardial enzyme spectrum is within the normal range (simple laboratory abnormalities that are deemed clinically insignificant by the researchers are also allowed to be included); 10. For female subjects of childbearing age, a urine or serum pregnancy test with negative results should be conducted within 3 days prior to the first administration of the study drug (Day 1 of the first cycle). If the urine pregnancy test result cannot be confirmed as negative, a blood pregnancy test is required. Non childbearing women are defined as those who have been postmenopausal for at least one year or have undergone surgical sterilization or hysterectomy; 11. If there is a risk of conception, male and female patients should use highly effective contraception (i.e. methods with an annual failure rate of less than 1%) and continue for at least 180 days after stopping the trial treatment. Note: If abstinence is the subject's usual lifestyle and preferred contraceptive method, then abstinence is acceptable as a contraceptive method; 12. Patients must have the ability to understand and voluntarily sign informed consent forms
Exclusion criteria
Exclusion criteria: Subjects who meet the following criteria are not eligible for this study: 1. Esophageal squamous cell carcinoma that tends to be completely obstructed under endoscopy and requires interventional treatment to relieve obstruction. 2. After esophageal or tracheal stent implantation surgery. 3. Patients with a higher risk of bleeding or perforation due to obvious invasion of adjacent organs (large arteries or trachea) of esophageal lesions by tumors, or patients who have already formed fistulas. 4. Medical history of other malignant tumors (except those that have been cured and have not recurred within 5 years, such as non melanoma skin cancer in situ, superficial bladder cancer cancer, cervical cancer in situ, gastrointestinal intramucosal cancer, and localized prostate cancer, which the researchers think can be included). 5. Individuals with a history of severe allergic diseases, severe drug allergies, or known allergies to any component of macromolecular protein preparations or KL-A167 injection prescriptions. 6. Previously received anti-PD-1 antibody, anti-PD-L1 antibody, anti-PD-L2 antibody, anti-CTLA-4 antibody, or CAR-T cell therapy (or any other antibody acting on T cell co stimulatory or checkpoint pathways). 7. Received anti-tumor vaccine within 3 months before the first administration. 8. Have received allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation, or have undergone autologous hematopoietic stem cell transplantation within 3 months before the first administration. 9. There is active infection or unexplained fever before the first administration. 10. Systemic use of antibiotics within the week prior to signing informed consent. 11. Any active autoimmune disease or history of autoimmune disease, including but not limited to immune related neurological disorders, multiple sclerosis, autoimmune (demyelinating) neuropathy, Guillain Barr é syndrome, myasthenia gravis, systemic lupus erythematosus (SLE), connective tissue disease, scleroderma, inflammatory bowel disease including Crohn's disease and ulcerative colitis, autoimmune hepatitis, toxic epidermal necrolysis (TEN) or Stevens Johnson syndrome. 12. Received systemic treatment with steroids (equivalent to>10 mg/day of prednisone) or other immunosuppressive agents within 14 days prior to the first administration. Note: Subjects without active immune disorders are allowed to receive adrenaline replacement therapy at a dose equivalent to prednisone = 10 mmol/L), poorly controlled hypertension (systolic blood pressure>150 mmHg and/or diastolic blood pressure>100 mmHg), and echocardiography shows ejection fraction450 milliseconds, female >470 milliseconds. 15. Abnormal electrocardiogram examination and researchers believe there are additional risks to the investigational drug. 16. Known pati
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| overall response rate;Disease control rates;overall survival; | — |
Countries
China
Contacts
Public ContactChangmin Liu
Anhui Provincial Cancer Hospital
Outcome results
None listed