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

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

Study Overview

• Status: Unknown
• Conditions: Esophagus Cancer, Stage III; Esophageal Gastric Cardia Type Metaplasia; Esophagus Cancer, Stage IV
• Intervention / Treatment: Drug: Apatinib

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• China
  • Tianjin
    • Tianjin, Tianjin, China, 300060
      • Recruiting
      • Tianjin Medical University Cancer Institute and Hospital
      • Contact: Pan Zhanyu, Master; Phone Number: 86-13752570372; Email: liyanwei127@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment group; Apatinib：500 mg，po，qd	Drug: Apatinib; Targeted therapy Apatinib：500 mg，po，qd; Other Names: YN968D1

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Tianjin Medical University Cancer Institute and Hospital
• Investigators: Principal Investigator: Pan Zhanyu, Master, 86-13752570372

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2017
• Primary Completion (Anticipated): June 1, 2019
• Study Completion (Anticipated): December 1, 2019

Study Registration Dates

• First Submitted: August 21, 2017
• First Submitted That Met QC Criteria: September 14, 2017
• First Posted (Actual): September 18, 2017

Study Record Updates

• Last Update Posted (Actual): September 18, 2017
• Last Update Submitted That Met QC Criteria: September 14, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Head and Neck Neoplasms; Esophageal Diseases; Esophageal Neoplasms; Metaplasia; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Protein Kinase Inhibitors; Apatinib
• Other Study ID Numbers: AHEAD-HBE001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: PFS data of patients in this trial are expected to be Shared

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No