Esophageal squamous cell carcinoma
Conditions
Interventions
Case Series:Anrotinib combined with chemoradiotherapy
Sponsors
Zhejiang Cancer Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Histologically or cytologically confirmed esophageal squamous cell carcinoma; 2. The surgeon evaluates it unresectable or the patient refuses the operation; 3. Never received systematic treatment for esophageal cancer before, with clear indications of radiotherapy and tolerance to concurrent chemoradiotherapy; 4. Endoscopic ultrasonography confirmed no definite invasion of the outer membrane of the esophagus (T1-3); 5. Stage IIA-IVA (AJCC 02 stage system); 6. Aged 18 to 70 years, with a life expectancy of at least 12 weeks; 7. KPS score = 70; 8. Left ventricular ejection fraction >50%; 9. Major organs function levels meet the following criteria: 1) The blood routine examination standards must be in accordance with: the ANC = 1.5 x 109 / L, PLT = 80 x 109 / L, Hb =100 G/L or higher (no blood transfusion and adjuvant therapies within 14 days, unused G-CSF or other hematopoietic stimulating factor; 2) Biochemical inspection must meet the following standards: TBIL < 1.5 x ULN, ALT and AST < 2.5 x ULN (patients with liver metastasis can be < 5 x ULN), BUN and Cr = 1 x ULN or endogenous creatinine clearance = 50ml/min (Cockcroft-Gault formula); 10. Women of child-bearing age must have taken reliable contraceptive measures or have had a pregnancy test (serum or urine) within 7 days of enrollment, which was negative, and be willing to use appropriate contraceptive methods during the trial and 8 weeks after the last administration of the test drug; 11. Subjects voluntarily participated in this study and signed the informed consent, with good compliance and follow-up.
Exclusion criteria
Exclusion criteria: 1. Esophageal squamous cell carcinoma patients with active bleeding within 2 months of the primary lesion; 2. Ulcerative esophageal cancer; 3. Primary esophageal lesions are closely related to trachea, bronchus and large blood vessels, with a high risk of perforation and massive bleeding; 4. Active brain metastasis and cancer meningitis (the group of 21 days prior treatment has been completed and the symptoms of patients with brain metastases from stable can into the group, but need to be confirmed by the cerebral MRI, CT or vein imaging evaluation for without symptoms of cerebral hemorrhage); 5. Use two kinds of antihypertensive drug combination therapy is still unable to control high blood pressure (systolic blood pressure 140 mmHg or diastolic blood pressure or 90 mmHg or higher); 6. With severe cardiovascular disease: II magnitude or higher myocardial ischemia and myocardial infarction, poor control of cardiac arrhythmias (including QTc = 470 ms or higher); According to NYHA standard, III ~ IV cardiac insufficiency, or heart colour ultrosound revealed left ventricular ejection fraction (LVEF) < 50%; 7. Abnormal coagulation function, or known genetic or acquired bleeding tendency and thrombosis tendency; 8. Received major surgery or suffered severe traumatic injury, fracture or ulcer within 4 weeks before enrollment; 9. Factors that significantly affect oral drug absorption, such as inability to consume fluids, chronic diarrhea and intestinal obstruction; 10. Abdominal fistula, gastrointestinal perforation or abdominal abscess occurred within 6 months before enrollment; 11. Urine routine test indicated urine protein = ++, or confirmed 24 hours urine protein = 1.0 g; 12. Have a history of psychotropic substance abuse and cannot quit or have a mental disorder; 13. Received chemotherapy, targeted therapy or other clinical trials of anti-tumor drugs within 4 weeks before enrollment; 14. Previous or concurrent cancer of other uncured malignant tumors, except cured basal cell carcinoma of the skin, carcinoma in situ of the cervix and superficial bladder cancer; 15. Pregnant or lactating women; Patients with fertility are unwilling or unable to take effective contraceptive measures; 16. The investigator judges other conditions that may affect the progress of clinical research and the judgment of research results.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival;Disease control rate;Objective remission rate; | — |
Countries
China
Contacts
Public ContactMing Chen
Outcome results
None listed