Apatinib Treatment for Advanced Esophagus Cancer

Study Overview
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Brief Summary
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Subject ever received a standard chemotherapy solution progression or recurrence or can't tolerate chemotherapy with advanced esophageal squamous carcinoma.

Official Title
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Apatinib Treatment for Advanced Esophagus Cancer ,One-armed，Exploratory，Openting , Clinical Trail.

Conditions
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Advanced Esophagus Cancer

Intervention / Treatment
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* Drug: Apatinib


Participation Criteria
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Eligibility Criteria
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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: blood routine examination: HB≥90 g / L; (without blood transfusion during 14 days) ANC≥1.5×109 /L; PLT≥80×109 / L; 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.

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

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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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> | Drug: Apatinib<br>* Apatinib500 mg,po,qd,continuous dosing until PD, death or not tolerated toxicity.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progress free survival | Time subject into the group to tumor objective progression. | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival | Time subject into the group to die. | up to 24 months |