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To compare the objective response rate (ORR) and safety of tislelizumab combined with chemotherapy and Tislelizumab combined with radiotherapy in elderly patients with esophageal cancer with advanced or recurrent metastasis
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tislelizumab combined with radiotherapy | Experimental |
| |
| Tislelizumab combined with chemotherapy | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tislelizumab | Drug | 200mg d1, Q3W |
|
| Measure | Description | Time Frame |
|---|---|---|
| objective response rate | Clinical response of treatment according to RESIST v1.1 criteria (ORR, objective response rate). | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| progression free survival | The length of time from enrollment until the time of progression of disease (PFS, progression-free survival). | 12 months |
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Inclusion Criteria:
A) Routine blood tests (no blood components, cell growth factors, whitening agents, platelets, anemia drugs are allowed within 14 days before the first use of the study drug) Leukocyte count was at 3.0109/L Neutrophil count was at 1.0109/L Platelet count was at 8,0109/L Hemoglobin was at 80 g / L b) Blood biochemical examination: Total bilirubin was at 1.5 ULN ALT ≤ 2.5×ULN ,AST ≤2.5×ULN , Serum creatinine of 1.5 ULN, or creatinine clearance of 45 mL/min (Cocheroft-Gault formula, see Annex 2)
-The subjects had good compliance and cooperated with the follow-up
Exclusion Criteria:
A) Any radiotherapy, chemotherapy, or other antitumor drugs directed against the tumor; Study drug b) Treatment with immunosuppressive drugs or systemic hormones for immunosuppression purposes within 2 weeks of the first study drug (dose or equivalent dose> 10mg / day); inhaled or topical steroids and doses> 10mg / day prednisone or equivalent dose of adrenal corticoid replacement in the absence of active autoimmune disease; The c) Acceptance of a live attenuated vaccine within 4 weeks before the first use of the study drug; d) Major surgery or severe trauma within 4 weeks prior to the first use of the study drug;
Such as (1) heart failure of grade NYHAII or above; (2) unstable angina pectoris; (3) myocardial infarction within 1 year; (4) clinical significance of supraventricular or ventricular arrhythmia without clinical intervention or clinical intervention is not well controlled;
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| Radiation | Radiation | Radiotherapy dose: 5,000 c G y / 30f |
|
| Paclitaxel | Drug | Paclitaxel: 150mg / m2 ,d1, q3w |
|
| Platinum: cisplatin, carboplatin, naidaplatin and other platinum drugs | Drug | cisplatin, carboplatin, naidaplatin and other platinum drugs |
|
| ID | Term |
|---|---|
| D004938 | Esophageal Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
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| ID | Term |
|---|---|
| C000707970 | tislelizumab |
| D011827 | Radiation |
| D017239 | Paclitaxel |
| D016190 | Carboplatin |
| ID | Term |
|---|---|
| D055585 | Physical Phenomena |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D056831 | Coordination Complexes |
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