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Study of Apatinib in Metastatic Esophageal Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02683655
Recruitment Status : Unknown
Verified February 2016 by Huai'an First People's Hospital.
Recruitment status was:  Recruiting
First Posted : February 17, 2016
Last Update Posted : February 17, 2016
Jiangsu HengRui Medicine Co., Ltd.
Information provided by (Responsible Party):
Huai'an First People's Hospital

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

Condition or disease Intervention/treatment Phase
Esophageal Cancer Drug: Apatinib Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Study of Apatinib in Metastatic Esophageal Cancer:A Open Label, Randomized Clinical Trial
Study Start Date : August 2015
Estimated Primary Completion Date : October 2016

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Apatinib 500mg qd p.o.
Apatinib Mesylate Tablets 500 mg qd p.o. after the failure of chemotherapy or radiotherapy
Drug: Apatinib
Apatinib 500mg qd p.o.

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

Primary Outcome Measures :
  1. Progression free survival [ Time Frame: An expected average of 12 weeks ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02683655

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Contact: Chen xiaofei, MD +86-13915107001

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China, Jiangsu
Huaian First People's Hospital Recruiting
Huaian, Jiangsu, China
Contact: Chen xiaofei, MD    +86-13915107001      
Sponsors and Collaborators
Huai'an First People's Hospital
Jiangsu HengRui Medicine Co., Ltd.
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Responsible Party: Huai'an First People's Hospital Identifier: NCT02683655    
Other Study ID Numbers: Ahead-E301
First Posted: February 17, 2016    Key Record Dates
Last Update Posted: February 17, 2016
Last Verified: February 2016
Additional relevant MeSH terms:
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Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action