Apatinib as First -Line Treatment for Advanced Esophagus Cancer

Study Overview
=================
Brief Summary
-----------------
An Exploratory study of Amapinib for patients with advanced esophagus cancer .

Detailed Description
-----------------
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.

Official Title
-----------------
An Exploratory and Open Clinical Study of Apatinib Mesylate as First-line Treatment for Advanced Esophagus Cancer.

Conditions
-----------------
Advanced Esophagus Cancer

Intervention / Treatment
-----------------
* Drug: Apatinib


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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Apatinib<br>Apatinib 500 mg,po,qd,continuous dosing until PD, death or not tolerated toxicity. | Drug: Apatinib<br>* Metastasis after primary treatment : Apatinib + yew + platinum. Local recurrence after previous surgery/radiotherapy: Apatinib alone or in combination with platinum-based chemotherapy.<br>* Other names: platinum;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progress free survival（PFS） | Time subject into the group to tumor objective progression. | 12months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival | Time subject into the group to die | up to12months |