Overview

Study of Apatinib in Metastatic Esophageal Cancer

Status:
Unknown status

Trial end date:
1969-12-31

Target enrollment:
0

Participant gender:
All

Summary

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

Phase:

Phase 2

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Huai'an First People's Hospital

Collaborator:

Jiangsu HengRui Medicine Co., Ltd.

Treatments:

Apatinib

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.