An Exploratory Clinical Study of Apatinib for the 2nd Treatment of Esophageal Cancer or Esophageal and Gastric

Esophagus Cancer, Stage III Clinical Trial

Official title:

An Exploratory Clinical Study of Apatinib for the 2nd Treatment of Esophageal Cancer or Esophageal and Gastric

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03285906
• Other study ID #: AHEAD-HBE001
• Status: Recruiting
• Phase: Phase 2/Phase 3
• First received: August 21, 2017
• Last updated: September 14, 2017
• Start date: March 1, 2017
• Est. completion date: December 2019

Study information

• Verified date: July 2017
• Source: Tianjin Medical University Cancer Institute and Hospital
• Contact: Pan Zhanyu, Master
• Phone: 86-13752570372
• Email: liyanwei127[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this Phase II, Open-label, single arm, exploratory study is to evaluate the efficacy and the safety of Apatinib（500mg/d）for the second - line treatment of esophageal cancer or esophageal and gastric

Description:

This study is a prospective,single-center,single arm,Ⅱ exploratory study.To explore the clinical study of the efficacy and safety of the treatment of vegfr-2 high expression by apatinib mesilate.The main research object for first-line treatment failure Ⅲ/Ⅳ integration of a period of esophageal or gastric esophagus cancer patients.The main purpose of the study was to evaluate apatinib for the median PFS of the esophageal and esophageal gastric junction carcinoma of the esophagus with high expression of VEGFR-2. The objective of secondary research is to evaluate the safety of apatinib for second-line treatment of esophageal and esophageal gastric junction cancer Objective Response Rate (CR + PR) and median OS and explore the relationship between VEGFR-2 high expression and apatinib efficacy and related prognostic factors. Thirty patients were enrolled in the study group. The group was expected to be enrolled in the group for 24 months, followed by 6 months of follow-up and 6 months of data statistics. The drug regimen was a single drug apatinib 500mg qd Po.Please refer to the CRF table for details.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 2019
• Est. primary completion date: June 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• = 18 and = 75 years of age

• Have failed for 1 lines of chemotherapy

• ECOG performance scale 0 - 2.

• Adequate hepatic, renal, heart, and hematologic functions (hemoglobin = 90g/L, platelets = 80×10^9/L, neutrophils = 1.5×10^9/L, total bilirubin within 1.25×the upper limit of normal(ULN), and serum transaminase=2.5×the ULN (If liver metastases, serum transaminase=5×the ULN), serum creatine = 1.5 x ULN, creatinine clearance rate = 50ml/min.

• Life expectancy of more than 12 months

Exclusion Criteria:

• Existing therapy related toxicity of prior chemotherapy and/or radiation therapy

• Intercurrence with one of the following: hypertension, coronary artery disease, arrhythmia and heart failure

• Any factors that influence the usage of oral administration

• The center of the tumor invaded local large blood vessels

• Within 4 weeks before the first use of drugs, occurs pulmonary hemorrhage (= CTCAE class 2) or other parts' hemorrhage (= CTCAE class 3).

• Within 6 months before the first treatment occurs artery / venous thromboembolic events, such as cerebral vascular accident (including transient ischemic attack), deep vein thrombosis and pulmonary embolism, etc.

• Less than 4 weeks from the last clinical trial

Related Conditions & MeSH terms

• Barrett Esophagus
• Esophageal Gastric Cardia Type Metaplasia
• Esophageal Neoplasms
• Esophagus Cancer, Stage III
• Esophagus Cancer, Stage IV
• Metaplasia

Intervention

Drug:
• Apatinib
Targeted therapy Apatinib:500 mg,po,qd

Locations

Country	Name	City	State
China	Tianjin Medical University Cancer Institute and Hospital	Tianjin	Tianjin

Sponsors (1)

Lead Sponsor	Collaborator
Tianjin Medical University Cancer Institute and Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	progression-free survival	No progress in survival (PFS) is to use the RECIST 1.1 standard to assess the progress of the evaluation of the population without progress.The date of the first occurrence of a disease or any cause of death from a random date to the first occurrence.	Through study completion, an average of 1 year
Secondary	Objective Response Rate	Objective Response Rate(ORR):The proportion of patients who have been reduced to a certain amount and maintained a certain amount of time, including the CR + PR case.	Through study completion, an average of 0.5 year
Secondary	median Overall Survival	median Overall Survival (mOS):It means that 50% of patients start from randomization to the time of death for any reason.	Through study completion, an average of 1.5 year