Clinical trial NCT02683655: Study of Apatinib in Metastatic Esophageal Cancer
Official title: Study of Apatinib in Metastatic Esophageal Cancer：A Open Label, Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Esophageal Cancer
Lead sponsor: Huai'an First People's Hospital
Sponsor class: OTHER
Collaborators: name: Jiangsu HengRui Medicine Co., Ltd.
First posted: 2016-02-17
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the efficacy and safety of apatinib in Metastatic Esophageal Cancer.

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

Eligibility criteria: Inclusion Criteria:

1. Age: 18 to75 years old;
2. 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);
3. Failed in first-line chemotherapy or radiotherapy treatment;
4. ECOG PS of 0-1;
5. An expected survival of ≥ 3 months;
6. 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;
7. 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
8. Patient has to voluntarily join the study and sign the Informed Consent Form for the study;
9. Researchers believe that patients can benefit;

Exclusion Criteria:

1. Pts with other malignant tumor at the same time or in the past.
2. Pregnant or lactating women;
3. 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%;
4. Factors that could have an effect on oral medication (such as inability to swallow, chronic diarrhea and intestinal obstruction);
5. 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;
6. Associated with CNS (central nervous system) metastases;
7. Abnormal Coagulation, with tendency of bleed;
8. With psychotropic drug abuse history and can't get rid of or mental disorder patients;
9. Anastomotic recurrence;
10. Participated in other clinical trials within 4 weeks;
11. Any other condition that might place the patient at undue risk or preclude a patient from completing the study;
12. Other conditions regimented at investigators' discretion.

Primary outcomes:
measure: Progression free survival
timeFrame: An expected average of 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Huaian
country: China
facility: Huaian First People's Hospital
state: Jiangsu
Study officials:
References: