Apatinib as First -Line Treatment for Advanced Esophagus Cancer

• Status: Unknown status
• Trial end date: 2019-05-01
• Target enrollment: 0
• Participant gender: All

Summary

An Exploratory study of Amapinib for patients with advanced esophagus cancer .

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Affiliated Hospital of North Sichuan Medical College
• Treatments: Apatinib

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:

1. blood routine examination: HB ≥ 90g/L (no blood transfusion within 14 days); ANC ≥ 1.5 × 109/L; PLT ≥ 80 × 109/L;

2. biochemical examination: ALB ≥ 29 g / L (AlB did not lose within 14 days); ALT and AST <5 ULN; TBIL ≤ 1.5 ULN;

3. 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.