Study of Apatinib in Metastatic Esophageal Cancer

Study Overview
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Brief Summary
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The purpose of this study is to assess the efficacy and safety of apatinib in Metastatic Esophageal Cancer.

Detailed Description
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Eligible patients will receive apatinib treatment until disease progression or intolerable toxicity or patients withdrawal of consent after the failure of chemotherapy or radiotherapy.

Official Title
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Study of Apatinib in Metastatic Esophageal Cancer：A Open Label, Randomized Clinical Trial

Conditions
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Esophageal Cancer

Intervention / Treatment
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* Drug: Apatinib
* Drug: Apatinib


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age: 18 to75 years old; Pathologically diagnosed with metastatic esophageal squamous cell cancer with measurable metastases outside the stomach (measuring ≥ 10mm on spiral CT scan, satisfying the criteria in RECIST 1.1); Failed in first-line chemotherapy or radiotherapy treatment; ECOG PS of 0-1; An expected survival of ≥ 3 months; No treated by molecularly targeted therapy. If have received chemotherapy, radiotherapy or surgery, must ≥4 weeks, and adverse reactions or wound has been completely restored; Major organ function has to meet the following criteria: ANC ≥ 1.5 × 109 / L; HB ≥ 90g / L; PLT ≥ 100 × 109 / L; ALB≥30g / L; TBIL≤1.5 times the upper limit of normal (ULN); ALT and AST<2 × ULN; Plasma Cr<1.5 × ULN Patient has to voluntarily join the study and sign the Informed Consent Form for the study; Researchers believe that patients can benefit; Exclusion Criteria: Pts with other malignant tumor at the same time or in the past. Pregnant or lactating women; Subjects with poor-controlled arterial hypertension (systolic blood pressure>150 mmHg and diastolic blood pressure>100 mm Hg) despite standard medical management; Coronary heart disease greater than ClassII; Echocardiography: LVEF (LVEF)<50%; Factors that could have an effect on oral medication (such as inability to swallow, chronic diarrhea and intestinal obstruction); Subjects with high gastrointestinal bleeding risk, including the following conditions: local active ulcer lesions with positive fecal occult blood test (++); history of black stool, or vomiting blood in the past 6 months; Associated with CNS (central nervous system) metastases; Abnormal Coagulation, with tendency of bleed; With psychotropic drug abuse history and can't get rid of or mental disorder patients; Anastomotic recurrence; Participated in other clinical trials within 4 weeks; Any other condition that might place the patient at undue risk or preclude a patient from completing the study; Other conditions regimented at investigators' discretion.

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Apatinib 500mg qd p.o.<br>Apatinib Mesylate Tablets 500 mg qd p.o. after the failure of chemotherapy or radiotherapy | Drug: Apatinib<br>* Apatinib 500mg qd p.o.<br>|
| Experimental: Apatinib 750mg qd p.o.<br>Apatinib Mesylate Tablets 750 mg qd p.o. after the failure of chemotherapy or radiotherapy | Drug: Apatinib<br>* Apatinib 750mg qd p.o.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression free survival |  | An expected average of 12 weeks |