Study of Apatinib in Metastatic Esophageal Cancer

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

• Status: Unknown
• Conditions: Esophageal Cancer
• Intervention / Treatment: Drug: Apatinib; Drug: Apatinib

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

Study Locations

• China
  • Jiangsu
    • Huaian, Jiangsu, China
      • Recruiting
      • Huaian First People's Hospital
      • Contact: Chen xiaofei, MD; Phone Number: +86-13915107001

Participation Criteria

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:

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Progression free survival	An expected average of 12 weeks

Collaborators and Investigators

• Sponsor: Huai'an First People's Hospital
• Collaborators: Jiangsu HengRui Medicine Co., Ltd.

Study record dates

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