Apatinib as First -Line Treatment for Advanced Esophagus Cancer

Advanced Esophagus Cancer Clinical Trial

Official title:

An Exploratory and Open Clinical Study of Apatinib Mesylate as First-line Treatment for Advanced Esophagus Cancer.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03542422
• Other study ID #: AHEAD-EC-201804
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: June 30, 2018
• Est. completion date: May 2019

Study information

• Verified date: June 2018
• Source: Af?liated Hospital of North Sichuan Medical College
• Contact: Daiyuan Ma
• Phone: 139 9088 9661
• Email: mdylx[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: May 2019
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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 ? or more myocardial ischemia or myocardial infarction, poorly controlled arrhythmia (including QTC interval=450ms) and ?~? 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.

Related Conditions & MeSH terms

• Advanced Esophagus Cancer
• Esophageal Neoplasms

Intervention

Drug:
• Apatinib
Metastasis after primary treatment : Apatinib + yew + platinum. Local recurrence after previous surgery/radiotherapy: Apatinib alone or in combination with platinum-based chemotherapy.

Locations

Country	Name	City	State
China	Affiliated Hospital of North Sichuan Medical College	Nanchong	Sichuan

Sponsors (1)

Lead Sponsor	Collaborator
Af?liated Hospital of North Sichuan Medical College

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progress free survival(PFS)	Time subject into the group to tumor objective progression.	12months
Secondary	Overall Survival	Time subject into the group to die	up to12months