Esophageal cancer
Conditions
Interventions
Test group:Carrelizumab combined with radiotherapy
Sponsors
Liaoning Cancer Hospital & Institute
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age: 18-75; 2. ECOG score is 0-2; 3. Esophageal squamous cell carcinoma was confirmed pathologically, and there was no progress at least 3 months after first-line treatment. Extracranial distant metastasis occurred, which was confirmed pathologically or imageologically (pathological results should be obtained as far as possible for metastatic lesions); 4. The number of metastatic lesions is 1-5, the maximum diameter is = 3cm, and at least one assessable lesion (RECIST1.1); 5. All metastatic lesions can receive radiotherapy safely; 6. Expected survival time > 6 months; 7. Organs function well, defined as follows: 1) Neutrophil count (ANC) = 1500/mm3 (1.5 × 109/L) 2) Platelet count (PLT) = 100000/mm3 (100 × 109/L) 3) Hemoglobin (Hb) = 9 g/dL (90 g/L); 4) Serum creatinine = 1.5 times the upper limit of normal value (UNL) or creatinine clearance = 60 ml/min; 5) Total bilirubin (TBIL) = 1.5 times the upper limit of normal value (UNL); 6) The level of AST/SGOT or ALT/SGPT = 2.5 times the upper limit of normal value (UNL); 7) International normalized ratio (INR) = 1.5, prothrombin time (PT) and activated partial thromboplastin time (APTT) = 1.5 times UNL; 8. Sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. There is local recurrence at the same time; 2. Central nervous system metastasis; 3. Pain, bleeding, obstruction, and near fracture caused by tumor need palliative radiotherapy to reduce symptoms; 4. Child Pugh B or C grade of liver function in patients with liver metastasis; 5. Malignant pleural effusion; 6. Complicated with serious basic diseases, unable to tolerate radiotherapy; 7. The planned radiotherapy organs have received radiotherapy in the past; 8. Active autoimmune diseases requiring systematic treatment (excluding alternative treatment) in the past 2 years; 9. Diagnose immune deficiency, receive chronic systemic steroid treatment or use any other form of immunosuppressant within seven days before the first medication of the study treatment, or have a history of organ transplantation (including allogeneic stem cell transplantation); 10. Active infection requiring systemic treatment; 11. Pregnancy, lactation or pregnancy expected during the study period; 12. Known allergy of any test drug or its excipient; 13. History of HIV, HBV or HCV infection; 14. History of active pulmonary tuberculosis; 15. Live vaccine shall be inoculated within 30 days before the first administration.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival;Overall survival;Local control rate;Quality of life evaluation;Correlation between TILs and clinical outcomes; | — |
Countries
China
Contacts
Public ContactNa Zhang
Liaoning Cancer Hospital
Outcome results
None listed