Study of Apatinib in Metastatic Esophageal Cancer

NCT ID: NCT02683655

Last Updated: 2016-02-17

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-08-31

Brief Summary

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

Detailed 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.

Conditions

Esophageal Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Apatinib 500mg qd p.o.

Apatinib Mesylate Tablets 500 mg qd p.o. after the failure of chemotherapy or radiotherapy

Group Type: EXPERIMENTAL

Apatinib

Intervention Type: DRUG

Apatinib 500mg qd p.o.

Apatinib 750mg qd p.o.

Apatinib Mesylate Tablets 750 mg qd p.o. after the failure of chemotherapy or radiotherapy

Group Type: EXPERIMENTAL

Apatinib

Intervention Type: DRUG

Apatinib 750mg qd p.o.

Interventions

Apatinib

Apatinib 500mg qd p.o.

Intervention Type: DRUG

Apatinib

Apatinib 750mg qd p.o.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jiangsu HengRui Medicine Co., Ltd.

INDUSTRY

Sponsor Role: collaborator

Huai'an First People's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Huaian First People's Hospital

Huaian, Jiangsu, China

Site Status: RECRUITING

Countries

China

Central Contacts

Chen xiaofei, MD

Role: CONTACT

+86-13915107001

Facility Contacts

Chen xiaofei, MD

Role: primary

+86-13915107001

Other Identifiers

Ahead-E301

Identifier Type: -

Identifier Source: org_study_id