a study of apatinib plus radiotherapy and s-1 for treatment of refractory or metastatic esophageal squamous cell carcinoma

Conditions: Refractory or Metastatic Esophageal Squamous Cell Carcinoma

Summary: the purpose of this study is to assess the efficacy and safety of patients who receive apatinib plus radiotherapy and s-1 for treatment of refractory or metastatic esophageal squamous cell carcinoma.


Eligibility criteria:
inclusion criteria: * 1. age:18 to 70 years old (man or female); 2. imageology diagnosed with refractory or metastatic esophageal squamous cell carcinoma(pathologically diagnosed with supraclavicular lymph node metastasis and anastomotic recurrence ); 3. the distant metastatic is oligotransfera, with radiotherapy indication; 4. patients with measurable lesions(measuring≥10mm on spiral ct scan, satisfying the criteria in recist1.1); 5. eastern cooperative oncology group (ecog) performance status of 0-2; 6. major organ function has to meet the following certeria: 1. for results of blood routine test (without blood transfusion within 14 days) 1. hb≥100g/l; 2. anc≥3.0×109/l; 3. plt≥100×109/l; 2. for results of blood biochemical test： 1. tbil\<1.5×uln； 2. alt and ast\<2.5×uln, but\< 5×uln if the transferanse elevation is due to liver metastases； 3. serum creatinine ≤1uln , calculated creatinine clearance\>50 ml/min(per the cockcroft-gault formula); 7. life expectancy greater than or equal to 3 months; 8. women of childbearing age must have contraceptive measures or have test pregnancy (serum or urine) enroll the study before 7 days, and the results must be negative, and take the methods of contraception during the test and the last to have drugs after 8 weeks. men must be contraception or has sterilization surgery during the test and the last to have drugs after 8 weeks; 9. coagulation function is normal, without active hemorrhage and thrombosis: 1. inr\<1.5×uln 2. aptt\<1.5×uln 3. pt\<1.5uln 10. participants were willing to join in this study, and written informed consent; 11. participants were good adherence, cooperate with the follow-up. exclusion criteria: * 1. allergic to apatinib; 2. have high blood pressure and antihypertensive drug treatment can not control (systolic blood pressure \> 140 mmhg, diastolic blood pressure \> 90 mmhg), with classⅱand above coronary heart disease and arrhythmia (including qtc lengthened men \> 450 ms, women \> 470 ms) and cardiac insufficiency; 3. a variety of factors influencing oral drugs (such as unable to swallow, nausea, vomiting, chronic diarrhea and intestinal obstruction, etc.); 4. patients with tendency of gastrointestinal bleeding, including the following; 1. active ulcerative lesions, and defecate occult blood (+ +); 2. has melena and hematemesis in three months; 3. for defecate occult blood (+) or(+/-) ,must be received gastroscopy, the physicians consider there are potential bleeding risk with ulcers, hemorrhagic diseases; 5. coagulant function abnormality (inr \> 1.5 uln, aptt \> 1.5 uln), with bleeding tendency; 6. patients with thrombosis or anticoagulant drug therapy; 7. patients with symptoms of central nervous system metastasis; patients with other malignant tumors within 5 years (except for the treated skin basal cell carcinoma and cervical carcinoma in situ); 8. history of psychiatric drugs abuse and can't quit or patients with mental disorders; 9. less than 4 weeks from the last clinical trial; 10. have received prior treatment with anti- vegf/vegfr; 11. researchers considered there are serious harm to patient safety or affect the patients who have completed the study; 12. pregnant or lactating women; 13. the researchers think inappropriate.