Efficacy and Safety of Apatinib for Recurrent or Metastatic Esophageal Squamous Cell Carcinoma

Inclusion criteria

• Patient age: ≥18 years old
• An ECOG score of 0-2
• Pathologically diagnosed with Esophageal Squamous Cell Carcinoma.
• At least second-line treatment failure regimens without targeted therapy.
• Measurable lesion.
• An expected survival of ≥ 3 months.
• Major organ function had to meet the following criteria:

1)For regular test results: HB(hemoglobin) ≥ 90g / L (14 days without blood transfusion); ANC(absolute neutrophil count) ≥ 1.5 × 109 / L; PLT(platelet) ≥ 80 × 109 / L 2)Biochemical tests results: Bilirubin <1.5 times the upper limit of normal (ULN) ALT(Alanine aminotransferase) and AST≤2.5 × ULN; liver metastases, if any, the ALT and AST≤5 × ULN; Endogenous creatinine clearance≥50ml/min (Cockcroft-Gault formula) 8. Informing consent.

Exclusion criteria

• Previously or presently suffering from other malignancies, except for the cured and stable carcinoma;
• Pregnant or lactating women;
• Participation in clinical trials with other drugs in the preceding four weeks.
• Factors that could have an effect on oral medication (such as inability to swallow, chronic diarrhea and intestinal obstruction).
• Serious bleeding events within 4weeks (≥3 degree)-CTCAE(Common Terminology Criteria for Adverse Events) 4.0
• Central nervous system metastasis or a history of central nervous system metastasis.
• Hypertension and antihypertensive drug treatment that does not normalize blood pressures (systolic blood pressure> 140 mmHg and diastolic blood pressure > 90 mm Hg); With unstable angina pectoris; Arrhythmia; Coronary heart disease greater than Class II; Angina pectoris diagnosed with 3 months or myocardial infarction event occurs within 6 months before recruiting.
• With the open wounds or fractura.
• A history of organ transplant.
• Coagulation dysfunction (PT(prothrombin time)>16 s, APTT(activated partial thromboplastin time)>43 s, TT(thrombin time)>21 s, Fbg(Fibrinogen)<2g/L), a tendency to bleed or receiving thrombolytic or anticoagulant therapy.
• A history of abuse of psychotropic drugs or mental disorders.
• Central nervous system disorders.
• A history of immunodeficiency.
• Arterial/venous thrombosis events within 12 months before recruiting.
• Use of CFDA(China Food and Drug Administration) approved anti-gastric modern traditional Chinese medicine preparations and immunomodulatory agents.