Clinical trial NCT03170310: Apatinib Treatment for Advanced Esophagus Cancer
Official title: Apatinib Treatment for Advanced Esophagus Cancer ,One-armed，Exploratory，Openting , Clinical Trail.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Advanced Esophagus Cancer
Lead sponsor: Henan Cancer Hospital
Sponsor class: OTHER_GOV
Collaborators: name: Jiangsu HengRui Medicine Co., Ltd.
First posted: 2017-05-31
Enrollment: 60
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: Subject ever received a standard chemotherapy solution progression or recurrence or can't tolerate chemotherapy with advanced esophageal squamous carcinoma.


Eligibility criteria: Inclusion Criteria:

* 1. Age: 18 to 75 years old, men and women;
* 2. After histopathological and immunohistochemical examination diagnosis of esophageal squamous cell carcinomas. At least one measurable lesion after the treatment (the length to diameter of CT scan≥10 mm , accord with the requirement of RESCIST 1.1);the lesions of whom had not received radiotherapy.
* 3. Advanced esophageal squamous cell carcinoma without molecular targeted drug therapy;
* 4. ECOG PS:0-1;
* 5. Life expectancy≥12 weeks;
* 6. Patients who have disease progressed or relapsed after standard chemotherapy, or who have been unable to tolerate chemotherapy;
* 7. The main organs function properly, that is, meet the following criteria:

  1. blood routine examination: HB≥90 g / L; (without blood transfusion during 14 days) ANC≥1.5×109 /L; PLT≥80×109 / L;
  2. biochemical examination: ALB≥30g / L; (without infusion of albumin during 14 days) ALT and AST\<2ULN; TBIL≤1.5ULN; Plasma Cr≤1.5ULN;
* 8. The results of the serum pregnancy test of women in childbearing age must be negative in the 7 days prior to treatment; all patients (both male and female) should take adequate barrier contraception within the entire treatment and 4 weeks after treatment.
* 9. Subject should volunteer to join the study, sign the informed consent, have good compliance and cooperate with the follow-up;
* 10. Investigator believe that subject who can benefit.

Exclusion Criteria:

* 1. In the past or at the same time with suffered from other malignancies;
* 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, significantly affect the drug taking and absorption;
* 5. With a clear risk of gastrointestinal bleeding (such as locally active ulcer lesions, fecal occult blood above + +), history of gastrointestinal bleeding within 6 months, and unhealed wounds;
* 6. Central nervous system metastasis has occurred;
* 7. With abnormal coagulation function (PT\>16s, APTT\>43s, TT\>21s, Fbg\<2g/L), with bleeding tendency or receiving thrombolytic or anticoagulant therapy;
* 8. With mental illness, or mental history of drug abuse;
* 9. With anastomotic recurrence;
* 10. Patients who have participated in other drug clinical trials in 4 weeks;
* 11. 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;
* 12. Patients those researchers believe not suitable for the inclusion.

Primary outcomes:
measure: Progress free survival
timeFrame: 24 months
Secondary outcomes:
measure: Overall survival
timeFrame: up to 24 months
Other outcomes:
Locations:
city: ZhengZhou
country: China
facility: Henan Cancer Hospital/The affiliated Cancer Hospital of ZhengZhou university
state: Henan
Study officials:
References: