Clinical trial NCT03542422: Apatinib as First -Line Treatment for Advanced Esophagus Cancer
Official title: An Exploratory and Open Clinical Study of Apatinib Mesylate as First-line Treatment for Advanced Esophagus Cancer.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Advanced Esophagus Cancer
Lead sponsor: Afﬁliated Hospital of North Sichuan Medical College
Sponsor class: OTHER
First posted: 2018-05-31
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Progress free survival（PFS）
timeFrame: 12months
Secondary outcomes:
measure: Overall Survival
timeFrame: up to12months
Other outcomes:
Locations:
city: Nanchong
country: China
facility: Affiliated Hospital of North Sichuan Medical College
state: Sichuan
Study officials:
References: