MedDataX Logo

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

NCT ID: NCT03285906

Last Updated: 2017-09-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-01

Study Completion Date

2019-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Treatment group

Apatinib：500 mg，po，qd

Group Type EXPERIMENTAL

Apatinib

Intervention Type DRUG

Targeted therapy Apatinib：500 mg，po，qd

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Apatinib

Targeted therapy Apatinib：500 mg，po，qd

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

YN968D1

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Tianjin Medical University Cancer Institute and Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Pan Zhanyu, Master

Role: PRINCIPAL_INVESTIGATOR

86-13752570372

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality, China

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Pan Zhanyu, Master

Role: CONTACT

[email protected]
86-13752570372

LI Yanwei, Master

Role: CONTACT

[email protected]
86-13920292059

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Pan Zhanyu, Master

Role: primary

[email protected]
86-13752570372

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

AHEAD-HBE001

Identifier Type: -

Identifier Source: org_study_id