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Study of Apatinib in Metastatic Esophageal Cancer

Primary Purpose

Esophageal Cancer

Status

Unknown status

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Apatinib

About this trial

This is an interventional treatment trial for Esophageal Cancer

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Age: 18 to75 years old;
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);
Failed in first-line chemotherapy or radiotherapy treatment;
ECOG PS of 0-1;
An expected survival of ≥ 3 months;
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;
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
Patient has to voluntarily join the study and sign the Informed Consent Form for the study;
Researchers believe that patients can benefit;

Exclusion Criteria:

Pts with other malignant tumor at the same time or in the past.
Pregnant or lactating women;
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%;
Factors that could have an effect on oral medication (such as inability to swallow, chronic diarrhea and intestinal obstruction);
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;
Associated with CNS (central nervous system) metastases;
Abnormal Coagulation, with tendency of bleed;
With psychotropic drug abuse history and can't get rid of or mental disorder patients;
Anastomotic recurrence;
Participated in other clinical trials within 4 weeks;
Any other condition that might place the patient at undue risk or preclude a patient from completing the study;
Other conditions regimented at investigators' discretion.

Sites / Locations

Huaian First People's HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Apatinib 500mg qd p.o.

Apatinib 750mg qd p.o.

Arm Description

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

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

Outcomes

Primary Outcome Measures

Progression free survival

Secondary Outcome Measures

Full Information

NCT ID

NCT02683655

First Posted

February 11, 2016

Last Updated

February 11, 2016

Sponsor

Huai'an First People's Hospital

Collaborators

Jiangsu HengRui Medicine Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT02683655

Brief Title

Study of Apatinib in Metastatic Esophageal Cancer

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2016

Overall Recruitment Status

Unknown status

Study Start Date

August 2015 (undefined)

Primary Completion Date

October 2016 (Anticipated)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Huai'an First People's Hospital

Collaborators

Jiangsu HengRui Medicine Co., Ltd.

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Esophageal Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Apatinib 500mg qd p.o.

Arm Type

Experimental

Arm Description

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

Arm Title

Apatinib 750mg qd p.o.

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Apatinib

Intervention Description

Apatinib 500mg qd p.o.

Intervention Type

Drug

Intervention Name(s)

Apatinib

Intervention Description

Apatinib 750mg qd p.o.

Primary Outcome Measure Information:

Title

Progression free survival

Time Frame

An expected average of 12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age: 18 to75 years old; 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); Failed in first-line chemotherapy or radiotherapy treatment; ECOG PS of 0-1; An expected survival of ≥ 3 months; 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; 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 Patient has to voluntarily join the study and sign the Informed Consent Form for the study; Researchers believe that patients can benefit; Exclusion Criteria: Pts with other malignant tumor at the same time or in the past. Pregnant or lactating women; 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%; Factors that could have an effect on oral medication (such as inability to swallow, chronic diarrhea and intestinal obstruction); 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; Associated with CNS (central nervous system) metastases; Abnormal Coagulation, with tendency of bleed; With psychotropic drug abuse history and can't get rid of or mental disorder patients; Anastomotic recurrence; Participated in other clinical trials within 4 weeks; Any other condition that might place the patient at undue risk or preclude a patient from completing the study; Other conditions regimented at investigators' discretion.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Chen xiaofei, MD

Phone

+86-13915107001

Facility Information:

Facility Name

Huaian First People's Hospital

City

Huaian

State/Province

Jiangsu

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Chen xiaofei, MD

Phone

+86-13915107001

12. IPD Sharing Statement

Learn more about this trial

Study of Apatinib in Metastatic Esophageal Cancer

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