- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02683655
Study of Apatinib in Metastatic Esophageal Cancer
February 11, 2016 updated by: Huai'an First People's Hospital
Study of Apatinib in Metastatic Esophageal Cancer:A Open Label, Randomized Clinical Trial
The purpose of this study is to assess the efficacy and safety of apatinib in Metastatic Esophageal Cancer.
Study Overview
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.
Study Type
Interventional
Enrollment (Anticipated)
40
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Chen xiaofei, MD
- Phone Number: +86-13915107001
Study Locations
-
-
Jiangsu
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Huaian, Jiangsu, China
- Recruiting
- Huaian First People's Hospital
-
Contact:
- Chen xiaofei, MD
- Phone Number: +86-13915107001
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Apatinib 500mg qd p.o.
Apatinib Mesylate Tablets 500 mg qd p.o. after the failure of chemotherapy or radiotherapy
|
Apatinib 500mg qd p.o.
Apatinib 750mg qd p.o.
|
Experimental: Apatinib 750mg qd p.o.
Apatinib Mesylate Tablets 750 mg qd p.o. after the failure of chemotherapy or radiotherapy
|
Apatinib 500mg qd p.o.
Apatinib 750mg qd p.o.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Progression free survival
Time Frame: An expected average of 12 weeks
|
An expected average of 12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2015
Primary Completion (Anticipated)
October 1, 2016
Study Registration Dates
First Submitted
February 11, 2016
First Submitted That Met QC Criteria
February 11, 2016
First Posted (Estimate)
February 17, 2016
Study Record Updates
Last Update Posted (Estimate)
February 17, 2016
Last Update Submitted That Met QC Criteria
February 11, 2016
Last Verified
February 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms
- Neoplasms by Site
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Head and Neck Neoplasms
- Esophageal Diseases
- Esophageal Neoplasms
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Protein Kinase Inhibitors
- Apatinib
Other Study ID Numbers
- Ahead-E301
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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