Apatinib Treatment for Advanced Esophagus Cancer

This is an interventional treatment trial for Advanced Esophagus Cancer Read More

Inclusion Criteria:

• 1. Age: 18 to 75 years old, men and women;
• 2. After histopathological and immunohistochemical examination diagnosis of esophageal squamous cell carcinomas. At least one measurable lesion after the treatment (the length to diameter of CT scan≥10 mm , accord with the requirement of RESCIST 1.1);the lesions of whom had not received radiotherapy.
• 3. Advanced esophageal squamous cell carcinoma without molecular targeted drug therapy;
• 4. ECOG PS:0-1;
• 5. Life expectancy≥12 weeks;
• 6. Patients who have disease progressed or relapsed after standard chemotherapy, or who have been unable to tolerate chemotherapy;

• 7. The main organs function properly, that is, meet the following criteria:

  1. blood routine examination: HB≥90 g / L; (without blood transfusion during 14 days) ANC≥1.5×109 /L; PLT≥80×109 / L;
  2. biochemical examination: ALB≥30g / L; (without infusion of albumin during 14 days) ALT and AST<2ULN; TBIL≤1.5ULN; Plasma Cr≤1.5ULN;
• 8. The results of the serum pregnancy test of women in childbearing age must be negative in the 7 days prior to treatment; all patients (both male and female) should take adequate barrier contraception within the entire treatment and 4 weeks after treatment.
• 9. Subject should volunteer to join the study, sign the informed consent, have good compliance and cooperate with the follow-up;
• 10. Investigator believe that subject who can benefit.

Exclusion Criteria:

• 1. In the past or at the same time with suffered from other malignancies;
• 2. Pregnant or lactating women;
• 3. Patients with high blood pressure and can't get a good control after antihypertensive drug therapy (systolic blood pressure>150mmHg, diastolic blood pressure>100mmHg); patients with grade Ⅱ or more myocardial ischemia or myocardial infarction, poorly controlled arrhythmia (including QTC interval≥450ms) and Ⅲ~Ⅳ grade cardiac insufficiency according to NYHA; cardiac color Doppler ultrasonography: LVEF <50%;
• 4. Unable to swallow, chronic diarrhea and intestinal obstruction, significantly affect the drug taking and absorption;
• 5. With a clear risk of gastrointestinal bleeding (such as locally active ulcer lesions, fecal occult blood above + +), history of gastrointestinal bleeding within 6 months, and unhealed wounds;
• 6. Central nervous system metastasis has occurred;
• 7. With abnormal coagulation function (PT>16s, APTT>43s, TT>21s, Fbg<2g/L), with bleeding tendency or receiving thrombolytic or anticoagulant therapy;
• 8. With mental illness, or mental history of drug abuse;
• 9. With anastomotic recurrence;
• 10. Patients who have participated in other drug clinical trials in 4 weeks;
• 11. Patients who have concomitant diseases that are seriously compromise the patient's safety or affect the patient to complete the study according to the researcher's judgment;
• 12. Patients those researchers believe not suitable for the inclusion.