Esophageal Cancer
Conditions
Interventions
Study group 1:
chemotherapy
Study group 2:
radiotherapy
Study group 3:operation
Study group 3:PD-1
Sponsors
National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences (CAMS) and Peking Union Medical College
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1.The patient volunteers to participate in the study, signs the informed consent, has good compliance, and obeys the follow-up, and is willing and able to follow the protocol during the study 2.Male or female, aged =18 years and =80 years 3.Histological and/or cytological confirmation of patients with esophageal squamous cell carcinoma 4.Clinical stage is T1-T4aN+M0 or T3-4aN0 5.At least one measurable lesion according to RECIST 1.1 6.The ECOG PS score is 0 or 1 and expected survival time=3 months 7.have adequate organ function and appropriate bone marrow reserve
Exclusion criteria
Exclusion criteria: 1. Previously received anlotinib hydrochloride, pembrolizumab; 2. Combined with supraclavicular lymph node metastasis; 3. Participated in clinical trials of other drugs or received systematic anti-tumor chemotherapy, radiotherapy or other anti-tumor treatments within the past 4 weeks; 4. Patients with high bleeding tendency; 5. Have received organ transplantation in the past; 6. Combined with other inoperable conditions; 7. Patients with any severe and/or uncontrolled disease, including: a) Patients with hypertension that cannot be well controlled by a single antihypertensive drug treatment (systolic blood pressure =150 mmHg, diastolic blood pressure =100 mmHg); or patients who use two or more antihypertensive drugs to control blood pressure; b) Patients with grade II or higher myocardial ischemia or myocardial infarction, arrhythmia (including QTc, male = 450ms; female = 470ms) and = grade 2 congestive heart failure (New York Heart Association (NYHA) classification); c) Active or uncontrolled serious infection (NCI-CTC AE grade = grade 2 infection); d) Liver cirrhosis, decompensated liver disease, active hepatitis or chronic hepatitis (hepatitis viral load>1000 IU/ml) require antiviral therapy; e) renal failure requiring hemodialysis or peritoneal dialysis; f) A history of immunodeficiency, including HIV positive or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation; g) A history of non-infectious pneumonia requiring systemic glucocorticoid therapy or current non-infectious pneumonia/interstitial lung disease; h) Poor blood sugar control in diabetic patients (fasting blood glucose (FBG)>10mmol/L); i) Urine routine indicates urine protein =++, and confirmed 24-hour urine protein quantification >1.0 g; j) Abnormal coagulation function (INR>1.5 or prothrombin time (PT)>ULN+4 seconds or APTT>1.5 ULN), with bleeding tendency or receiving thrombolysis or anticoagulation therapy; Note: as long as before starting study treatment Prophylactic use of low-dose heparin (ie, enoxaparin 40 mg/day) or low-dose aspirin (daily dose = 100) is permitted provided that the drug activity within 14 days results in an international normalized ratio (INR) of prothrombin time = 1.5 mg); k) There is any unresolved toxic reaction caused by previous treatment that is higher than NCI-CTC AE grade 1 or higher, or has not fully recovered from previous surgery; l) Patients with epileptic seizures and in need of treatment; 8. Patients requiring systemic therapy with corticosteroids (> 10 mg/day prednisone equivalent dose) or other immunosuppressive drugs within 7 days prior to study drug administration. Except for the following: a) In the absence of active autoimmune disease, inhaled or topical steroids and adrenal corticosteroids at doses greater than the therapeutic dose of 10 mg/day prednisone are permitted. b) The dosage of systemic glucocorticoids at physiological doses does not exceed 10 mg/day of prednisone or other glucocorticoids at equivalent doses. c) Glucocorticoids are used as a preventive drug for hypersensitivity reactions (such as before CT examination); 9. Inoculated with live vaccine or attenuated vaccine within 30 days before the first study drug administration, or planned to receive live vaccine or attenuated vaccine during the study period; 10. Those with multiple factors that affect oral drugs (such as inability to swallow, chronic diarrhea, etc.); 11. Severe drug allergic reactio
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 2-year event free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Recurrence free survival;R0 resection rate;Postoperative complications;Adverse events of chemotherapy or radiotherapy;Immunotherapy Related Adverse events;Pathological response; | — |
Countries
China
Contacts
Public ContactYong Li
National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences (CAMS) and Peking Union Medical College
Outcome results
None listed