Apatinib for Metastatic Esophageal Cancer.

• Register: ClinicalTrials.gov
• Last refreshed on: 5 September 2016
• Main ID: NCT02544737
• Date of registration: 06/09/2015
• Prospective Registration: No
• Primary sponsor: Hangzhou Cancer Hospital
• Public title: Apatinib for Metastatic Esophageal Cancer.
• Scientific title: A Phase II Study of Apatinib for Patients With Heavily Pretreated, Metastatic Esophageal Cancer.
• Date of first enrolment: September 2015
• Target sample size: 29
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/show/NCT02544737
• Study type: Interventional
• Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 2

Countries of recruitment

China

Contacts

• Name: Shixiu Wu, MD

• Name: Shixiu Wu, MD

• Name: Shixiu Wu, MD
• Affiliation: Hangzhou Cancer Hospital

Key inclusion & exclusion criteria

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.



Age minimum: 19 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Esophageal Cancer

Metastatic Esophageal Cancer

Apatinib

Intervention(s)

Drug: Apatinib

Primary Outcome(s)

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(s)

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]

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]

Secondary ID(s)

HangzhouCH

Source(s) of Monetary Support

Please refer to primary and secondary sponsors