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Apatinib for Metastatic Esophageal Cancer.

Primary Purpose

Esophageal Cancer, Metastatic Esophageal Cancer, Apatinib

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Apatinib
Sponsored by
Hangzhou Cancer Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Esophageal Cancer focused on measuring Esophageal cancer, Metastatic esophageal cancer, Apatinib

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Patients with histologically confirmed esophageal cancer which is persistent and metastatic or recurrent and metastatic;
  2. Patients must have distinct measurable metastatic sites at least 1 cm of larger in their largest diameter;
  3. Age ≥18 years;
  4. Metastatic disease measurable on a CT/MRI scan. The primary tumor is not considered measurable disease. Metastatic lesions within a prior radiation field are acceptable as long as disease has progressed in the radiation field by RECIST criteria. The same imaging modality performed at baseline (CT or MRI) will be repeated at subsequent imaging.
  5. ECOG performance status: 0-1;
  6. Life expectancy ≥ 3 months.
  7. Patients have adequate baseline organ and marrow function as defined by an absolute neutrophil count greater than 1500 cells per μL, platelet concentration of greater than 50 000 per μL, total bilirubin less than 1•5 times the upper limit of normal (ULN), aspartate aminotransferase and alanine aminotransferase less than 2•5 times the ULN, and serum creatinine less than 1•5 times the ULN;
  8. Signed consent forms voluntarily;

Exclusion Criteria:

  1. Patients who have had prior allergic reaction to Apatinib;
  2. Patients undergoing therapy with other investigational agents.
  3. Women who are pregnant or breastfeeding;
  4. Patients with known brain metastases can be included in this clinical trial but brain lesions are not eligible as target or non target lesion;
  5. Anticipated patient survival under 3 months;
  6. Active severe infection or known chronic infection with HIV, hepatitis B virus, or hepatitis C virus;
  7. Cardiovascular disease problems including unstable angina, therapy for life-threatening ventricular arrhythmia, myocardial infarction, stroke or congestive heart failure within the last 6 months;
  8. The subject has had another active malignancy within the past five years except for cervical cancer in site, in situ carcinoma of the bladder or non-melanoma carcinoma of the skin;
  9. Clinically significant and uncontrolled major medical conditions including but not limited to: active uncontrolled infection, symptomatic congestive heart failure, Unstable angina pectoris or cardiac arrhythmia, psychiatric illness/ social situation that would limit compliance with study requirements; any medical condition, which in the opinion of the study investigator places the subject at an unacceptably high risk for toxicities;
  10. Patients with any other concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for participation in the study.

Sites / Locations

  • Hangzhou Cancer HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Apatinib arm

Arm Description

Patients with metastatic lesions of esophageal cancer after been treated with surgery or definitive chemoradiotherapy receiving Apatinib (850mg) daily over 4 weeks.

Outcomes

Primary Outcome Measures

The proportion of patients with response (CR, PR, SD and PD based on RECIST version 1.0) assessed at 5-6 weeks after the initiation of treatment.

Secondary Outcome Measures

The number of participants with adverse events from the date of enrollment until 2 years from the opening of the study.
The proportion of patients alive (overall survival rate) from the date of enrollment until date of death from any cause, assessed up to 2 years from the opening of the study.

Full Information

First Posted
September 6, 2015
Last Updated
August 25, 2016
Sponsor
Hangzhou Cancer Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02544737
Brief Title
Apatinib for Metastatic Esophageal Cancer.
Official Title
A Phase II Study of Apatinib for Patients With Heavily Pretreated, Metastatic Esophageal Cancer.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Unknown status
Study Start Date
September 2015 (undefined)
Primary Completion Date
December 2016 (Anticipated)
Study Completion Date
December 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hangzhou Cancer Hospital

4. Oversight

5. Study Description

Brief Summary
Patients with esophageal cancer that had metastatic lesions after been treated with surgery or definitive chemoradiotherapy are being asked to participate in this study. Apatinib is a small-molecule vascular endothelial growth factors receptor (VEGFR) tyrosine kinase inhibitor, similar to vatalanib (PTK787), but with a binding affinity 10 times that of vatalanib or sorafenib. The purpose of this study is to determine what effects apatinib has on metastatic esophageal cancer. These effects include whether apatinib could shrink the tumor or slow down its growth and what side effects apatinib will have on the tumor.
Detailed Description
The purpose of this study is to determine what effects apatinib has on metastatic esophageal cancer patients after been treated with surgery or definitive chemoradiotherapy. These effects include whether apatinib could shrink the tumor or slow down its growth and what side effects apatinib will have on the tumor. Eligible are patients with metastatic esophageal cancer who have achieved stable disease or have disease progression after systemic therapy (surgery or definitive chemoradiotherapy) and have at least one separate measurable sites of metastatic lesions. Extent of metastatic disease is recorded either at CT or MRI scanning. Apatinib (850mg) is given daily during the therapy for 28 days. Tumor response is evaluated by assessing clinical and CT/MRI response in the metastatic sites. A Phase II clinical trial based on an optimum two-stage Phase II Simon design is used to conduct this pilot study. Ten patients will be treated in Stage one; if there are no tumor responses, the trial will be terminated. If there are one or more responses in Stage One, the trial will proceed to enroll an additional 19 patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Cancer, Metastatic Esophageal Cancer, Apatinib
Keywords
Esophageal cancer, Metastatic esophageal cancer, Apatinib

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
29 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Apatinib arm
Arm Type
Experimental
Arm Description
Patients with metastatic lesions of esophageal cancer after been treated with surgery or definitive chemoradiotherapy receiving Apatinib (850mg) daily over 4 weeks.
Intervention Type
Drug
Intervention Name(s)
Apatinib
Intervention Description
Patients with metastatic lesions of esophageal cancer after been treated with surgery or definitive chemoradiotherapy receiving Apatinib (850mg) daily over 4 weeks.
Primary Outcome Measure Information:
Title
The proportion of patients with response (CR, PR, SD and PD based on RECIST version 1.0) assessed at 5-6 weeks after the initiation of treatment.
Time Frame
week 5- week 6
Secondary Outcome Measure Information:
Title
The number of participants with adverse events from the date of enrollment until 2 years from the opening of the study.
Time Frame
year 0- year 2
Title
The proportion of patients alive (overall survival rate) from the date of enrollment until date of death from any cause, assessed up to 2 years from the opening of the study.
Time Frame
year 0- year 2

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with histologically confirmed esophageal cancer which is persistent and metastatic or recurrent and metastatic; Patients must have distinct measurable metastatic sites at least 1 cm of larger in their largest diameter; Age ≥18 years; Metastatic disease measurable on a CT/MRI scan. The primary tumor is not considered measurable disease. Metastatic lesions within a prior radiation field are acceptable as long as disease has progressed in the radiation field by RECIST criteria. The same imaging modality performed at baseline (CT or MRI) will be repeated at subsequent imaging. ECOG performance status: 0-1; Life expectancy ≥ 3 months. Patients have adequate baseline organ and marrow function as defined by an absolute neutrophil count greater than 1500 cells per μL, platelet concentration of greater than 50 000 per μL, total bilirubin less than 1•5 times the upper limit of normal (ULN), aspartate aminotransferase and alanine aminotransferase less than 2•5 times the ULN, and serum creatinine less than 1•5 times the ULN; Signed consent forms voluntarily; Exclusion Criteria: Patients who have had prior allergic reaction to Apatinib; Patients undergoing therapy with other investigational agents. Women who are pregnant or breastfeeding; Patients with known brain metastases can be included in this clinical trial but brain lesions are not eligible as target or non target lesion; Anticipated patient survival under 3 months; Active severe infection or known chronic infection with HIV, hepatitis B virus, or hepatitis C virus; Cardiovascular disease problems including unstable angina, therapy for life-threatening ventricular arrhythmia, myocardial infarction, stroke or congestive heart failure within the last 6 months; The subject has had another active malignancy within the past five years except for cervical cancer in site, in situ carcinoma of the bladder or non-melanoma carcinoma of the skin; Clinically significant and uncontrolled major medical conditions including but not limited to: active uncontrolled infection, symptomatic congestive heart failure, Unstable angina pectoris or cardiac arrhythmia, psychiatric illness/ social situation that would limit compliance with study requirements; any medical condition, which in the opinion of the study investigator places the subject at an unacceptably high risk for toxicities; Patients with any other concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for participation in the study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shixiu Wu, MD
Phone
+8657186826086
Email
wushixiu@medmail.com.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Tao Song, Dr
Phone
+8657186826086
Email
taosong01@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shixiu Wu, MD
Organizational Affiliation
Hangzhou Cancer Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Hangzhou Cancer Hospital
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shixiu Wu, MD
Phone
+8657186826086
Email
wushixiu@medmail.com.cn
First Name & Middle Initial & Last Name & Degree
Tao Song, Dr
Phone
+8657186826086
Email
taosong01@hotmail.com

12. IPD Sharing Statement

Citations:
PubMed Identifier
26095785
Citation
Golden EB, Chhabra A, Chachoua A, Adams S, Donach M, Fenton-Kerimian M, Friedman K, Ponzo F, Babb JS, Goldberg J, Demaria S, Formenti SC. Local radiotherapy and granulocyte-macrophage colony-stimulating factor to generate abscopal responses in patients with metastatic solid tumours: a proof-of-principle trial. Lancet Oncol. 2015 Jul;16(7):795-803. doi: 10.1016/S1470-2045(15)00054-6. Epub 2015 Jun 18.
Results Reference
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PubMed Identifier
23918952
Citation
Li J, Qin S, Xu J, Guo W, Xiong J, Bai Y, Sun G, Yang Y, Wang L, Xu N, Cheng Y, Wang Z, Zheng L, Tao M, Zhu X, Ji D, Liu X, Yu H. Apatinib for chemotherapy-refractory advanced metastatic gastric cancer: results from a randomized, placebo-controlled, parallel-arm, phase II trial. J Clin Oncol. 2013 Sep 10;31(26):3219-25. doi: 10.1200/JCO.2013.48.8585. Epub 2013 Aug 5.
Results Reference
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Apatinib for Metastatic Esophageal Cancer.

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