Apatinib for Metastatic Esophageal Cancer.

NCT02544737 | Unknown Phase 2

• 1 other identifier: HangzhouCH
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

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.

Conditions

Esophageal Cancer; Metastatic Esophageal Cancer; Apatinib

Keywords

Esophageal cancer; Metastatic esophageal cancer; Apatinib

Outcome Measures

Primary Outcomes (1)

• 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.

  week 5- week 6

Secondary Outcomes (2)

• The number of participants with adverse events from the date of enrollment until 2 years from the opening of the study.

  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.

  year 0- year 2

Study Arms (1)

Apatinib arm

EXPERIMENTAL

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

Drug: Apatinib

Interventions

Apatinib DRUG

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

Apatinib arm

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hangzhou Cancer Hospital: lead

Study Sites (1)

Hangzhou Cancer Hospital

Hangzhou, Zhejiang, 310000, China

RECRUITING

Related Publications (2)

• 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.

  PMID: 26095785 BACKGROUND

• 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.

  PMID: 23918952 BACKGROUND

MeSH Terms

Conditions

Esophageal Neoplasms

Interventions

apatinib

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Study Officials

• Shixiu Wu, MD

  Hangzhou Cancer Hospital

  STUDY CHAIR

Central Study Contacts

Shixiu Wu, MD

CONTACT

+8657186826086; wushixiu@medmail.com.cn

Tao Song, Dr

CONTACT

+8657186826086; taosong01@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: September 6, 2015
• First Posted: September 9, 2015
• Study Start: September 1, 2015
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2017
• Last Updated: August 26, 2016

Record last verified: 2016-08

Locations

CN (1)