An Exploratory study of Amapinib for patients with advanced esophagus cancer .

An Exploratory study of Amapinib for patients with advanced esophagus cancer .

Eligible are patients with advanced esophagus cancer. Apatinib (500mg) is given daily as follows:

Metastasis after primary treatment : Apatinib + yew + platinum. Local recurrence after previous surgery/radiotherapy: Apatinib alone or in combination with platinum-based chemotherapy One therapy cycle has 28 days. Tumor response is evaluated every 2 cycles.

Inclusion Criteria:

• 1. Age: 18 to 75 years old, men and women;

• 2. Patients diagnosed with esophageal squamous cell carcinoma by histopathology and immunohistochemistry;

• 3. ECOG performance status: 0-2;

• 4. Life expectancy ≥ 12 weeks;

• 5. Clinical stage IIIb-IV; metastatic patients who have not initially received chemotherapy or patients who have local recurrence after surgery or radiochemotherapy (no local treatment indication) ;

• 6. Function of the major organs is normal, criteria referred are as follow:

  1. blood routine examination: HB ≥ 90g/L (no blood transfusion within 14 days); ANC ≥ 1.5 × 109/L; PLT ≥ 80 × 109/L;
  2. biochemical examination: ALB ≥ 29 g / L (AlB did not lose within 14 days); ALT and AST <5 ULN; TBIL ≤ 1.5 ULN;
  3. plasma examination Cr ≤ 1.5 ULN;

• 7. Subjects voluntarily participated in the study, signed informed consent, have good compliance and cooperate with follow-up;

• 8. Patients that the investigator believes can benefit.

Exclusion Criteria:

• 1. Those who have had other malignant tumors in the past or at the same time;
• 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, which significantly affects drug taking and absorption;
• 5. Have a clear risk of gastrointestinal bleeding concerns (such as local active ulcer lesions, fecal occult blood + or more), a history of gastrointestinal bleeding within 6 months;
• 6.With coagulation abnormalities (PT>16 s, APTT>43 s, TT>21 s, Fbg <2 g/L), hemorrhagic tendency or receiving thrombolysis or anticoagulant therapy;
• 7. Have a mental illness, or history of abuse of psychotropic substances;
• 8. With anastomotic recurrence and tracheal fistula;
• 9. Patients who participated in other drug clinical trials within 4 weeks;
• 10. 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;
• 11. Researchers believe that it is not suitable for inclusion.