Advanced Esophagus Cancer
Conditions
Brief summary
An Exploratory study of Amapinib for patients with advanced esophagus cancer .
Detailed 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.
Interventions
DRUGApatinib
Metastasis after primary treatment : Apatinib + yew + platinum. Local recurrence after previous surgery/radiotherapy: Apatinib alone or in combination with platinum-based chemotherapy.
Sponsors
Affiliated Hospital of North Sichuan Medical College
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progress free survival（PFS） | 12months | Time subject into the group to tumor objective progression. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival | up to12months | Time subject into the group to die |
Countries
China
Contacts
Primary ContactDaiyuan Ma
Outcome results
None listed