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

Primary Purpose

Esophagus Cancer, Stage III, Esophageal Gastric Cardia Type Metaplasia, Esophagus Cancer, Stage IV

Status

Unknown status

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Apatinib

About this trial

This is an interventional screening trial for Esophagus Cancer, Stage III

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Tianjin Medical University Cancer Institute and HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment group

Arm Description

Apatinib：500 mg，po，qd

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

median Overall Survival

median Overall Survival (mOS):It means that 50% of patients start from randomization to the time of death for any reason.

Full Information

NCT ID

NCT03285906

First Posted

August 21, 2017

Last Updated

September 14, 2017

Sponsor

Tianjin Medical University Cancer Institute and Hospital

1. Study Identification

Unique Protocol Identification Number

NCT03285906

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2017

Overall Recruitment Status

Unknown status

Study Start Date

March 1, 2017 (Actual)

Primary Completion Date

June 2019 (Anticipated)

Study Completion Date

December 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Tianjin Medical University Cancer Institute and Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief 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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Esophagus Cancer, Stage III, Esophageal Gastric Cardia Type Metaplasia, Esophagus Cancer, Stage IV

7. Study Design

Primary Purpose

Screening

Study Phase

Phase 2, Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Treatment group

Arm Type

Experimental

Arm Description

Apatinib：500 mg，po，qd

Intervention Type

Drug

Intervention Name(s)

Apatinib

Other Intervention Name(s)

YN968D1

Intervention Description

Targeted therapy Apatinib：500 mg，po，qd

Primary Outcome Measure Information:

Title

progression-free survival

Description

Time Frame

Through study completion, an average of 1 year

Secondary Outcome Measure Information:

Title

Objective Response Rate

Description

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.

Time Frame

Through study completion, an average of 0.5 year

Title

median Overall Survival

Description

median Overall Survival (mOS):It means that 50% of patients start from randomization to the time of death for any reason.

Time Frame

Through study completion, an average of 1.5 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Pan Zhanyu, Master

Phone

86-13752570372

liyanwei127@hotmail.com

First Name & Middle Initial & Last Name or Official Title & Degree

LI Yanwei, Master

Phone

86-13920292059

liyanwei127@hotmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pan Zhanyu, Master

Organizational Affiliation

86-13752570372

Official's Role

Principal Investigator

Facility Information:

Facility Name

Tianjin Medical University Cancer Institute and Hospital

City

Tianjin

State/Province

Tianjin

ZIP/Postal Code

300060

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Pan Zhanyu, Master

Phone

86-13752570372

liyanwei127@hotmail.com

12. IPD Sharing Statement

Plan to Share IPD

Undecided

IPD Sharing Plan Description

PFS data of patients in this trial are expected to be Shared

Learn more about this trial

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

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