Study of Apatinib in Metastatic Esophageal Cancer

Esophageal Cancer Clinical Trial

Official title:

Study of Apatinib in Metastatic Esophageal Cancer：A Open Label, Randomized Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02683655
• Other study ID #: Ahead-E301
• Status: Recruiting
• Phase: Phase 2
• First received: February 11, 2016
• Last updated: February 11, 2016
• Start date: August 2015

Study information

• Verified date: February 2016
• Source: Huai'an First People's Hospital
• Contact: Chen xiaofei, MD
• Phone: +86-13915107001
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to assess the efficacy and safety of apatinib in Metastatic Esophageal Cancer.

Description:

Eligible patients will receive apatinib treatment until disease progression or intolerable toxicity or patients withdrawal of consent after the failure of chemotherapy or radiotherapy.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Age: 18 to75 years old;

2. Pathologically diagnosed with metastatic esophageal squamous cell cancer with measurable metastases outside the stomach (measuring = 10mm on spiral CT scan, satisfying the criteria in RECIST 1.1);

3. Failed in first-line chemotherapy or radiotherapy treatment;

4. ECOG PS of 0-1;

5. An expected survival of = 3 months;

6. No treated by molecularly targeted therapy. If have received chemotherapy, radiotherapy or surgery, must =4 weeks, and adverse reactions or wound has been completely restored;

7. Major organ function has to meet the following criteria:

ANC = 1.5 × 109 / L; HB = 90g / L; PLT = 100 × 109 / L; ALB=30g / L; TBIL=1.5 times the upper limit of normal (ULN); ALT and AST<2 × ULN; Plasma Cr<1.5 × ULN

8. Patient has to voluntarily join the study and sign the Informed Consent Form for the study;

9. Researchers believe that patients can benefit;

Exclusion Criteria:

1. Pts with other malignant tumor at the same time or in the past.

2. Pregnant or lactating women;

3. Subjects with poor-controlled arterial hypertension (systolic blood pressure>150 mmHg and diastolic blood pressure>100 mm Hg) despite standard medical management; Coronary heart disease greater than ClassII; Echocardiography: LVEF (LVEF)<50%;

4. Factors that could have an effect on oral medication (such as inability to swallow, chronic diarrhea and intestinal obstruction);

5. Subjects with high gastrointestinal bleeding risk, including the following conditions: local active ulcer lesions with positive fecal occult blood test (++); history of black stool, or vomiting blood in the past 6 months;

6. Associated with CNS (central nervous system) metastases;

7. Abnormal Coagulation, with tendency of bleed;

8. With psychotropic drug abuse history and can't get rid of or mental disorder patients;

9. Anastomotic recurrence;

10. Participated in other clinical trials within 4 weeks;

11. Any other condition that might place the patient at undue risk or preclude a patient from completing the study;

12. Other conditions regimented at investigators' discretion.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Esophageal Cancer
• Esophageal Neoplasms

Intervention

Drug:
• Apatinib
Apatinib 500mg qd p.o.
• Apatinib
Apatinib 750mg qd p.o.

Locations

Country	Name	City	State
China	Huaian First People's Hospital	Huaian	Jiangsu

Sponsors (2)

Lead Sponsor	Collaborator
Huai'an First People's Hospital	Jiangsu HengRui Medicine Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression free survival		An expected average of 12 weeks	No