Apatinib as First -Line Treatment for Advanced Esophagus Cancer

Afﬁliated Hospital of North Sichuan Medical College

Status and phase

Unknown

Phase 2

Conditions

Advanced Esophagus Cancer

Treatments

Drug: Apatinib

Study type

Interventional

Funder types

Other

Identifiers

NCT03542422

AHEAD-EC-201804

Details and patient eligibility

About

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

Full description

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

Eligible are patients with advanced esophagus cancer. Apatinib (500mg) is given daily as follows:

Metastasis after primary treatment : Apatinib + yew + platinum. Local recurrence after previous surgery/radiotherapy: Apatinib alone or in combination with platinum-based chemotherapy One therapy cycle has 28 days. Tumor response is evaluated every 2 cycles.

Enrollment

50 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

1. Age: 18 to 75 years old, men and women;
1. Patients diagnosed with esophageal squamous cell carcinoma by histopathology and immunohistochemistry;
1. ECOG performance status: 0-2;
1. Life expectancy ≥ 12 weeks;
1. 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) ;
1. Function of the major organs is normal, criteria referred are as follow:
2. blood routine examination: HB ≥ 90g/L (no blood transfusion within 14 days); ANC ≥ 1.5 × 109/L; PLT ≥ 80 × 109/L;
3. biochemical examination: ALB ≥ 29 g / L (AlB did not lose within 14 days); ALT and AST <5 ULN; TBIL ≤ 1.5 ULN;
4. plasma examination Cr ≤ 1.5 ULN;
1. Subjects voluntarily participated in the study, signed informed consent, have good compliance and cooperate with follow-up;
1. 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;
1. Pregnant or lactating women;
1. 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%;
1. Unable to swallow, chronic diarrhea, and intestinal obstruction, which significantly affects drug taking and absorption;
1. 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;
1. Have a mental illness, or history of abuse of psychotropic substances;
1. With anastomotic recurrence and tracheal fistula;
1. Patients who participated in other drug clinical trials within 4 weeks;
1. 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;
1. Researchers believe that it is not suitable for inclusion.