The Real World Study of Apatinib for Gastric Cancer Treat... | NCT03478943

Studies
The Real World Study of Apatinib for Gastric Cancer Treatment in Henan Province

NCT03478943

Sponsor

Henan Cancer Hospital

Status

Unknown status

Last Update Posted

May 28, 2020Actual

Enrollment

1,000Estimated

Phase

Not provided

Conditions

Gastric Cancer

Interventions

Not provided

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 30, 2016Actual

Primary Completion Date

Aug 1, 2020Estimated

Completion Date

Dec 1, 2020Estimated

First Submitted Date

Mar 20, 2018

First Submission Date that Met QC Criteria

Mar 20, 2018

First Posted Date

Mar 27, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 26, 2020

Last Update Posted Date

May 28, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The investigators conduct the real world study to explore the efficacy and safety of Apatinib in gastric cancer .

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,000Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Progress free survival		1 year
Disease-free surviva		1 year

Secondary Outcomes

Measure	Description	Time Frame
overall survival		3 year
Objective Response Rate		1 year
Disease Control Rate

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Male or female patients .
Confirmed by Pathology or histology of Gastric cancer.
Patients should be voluntary to the trial and provide with signed informed consent.
The researchers believe patients can benefit from the study.

Exclusion Criteria:

Patients with a known history of allergic reactions and/or hypersensitivity attributed to apatinib or its accessories.
Pregnant or lactating women.
Patients with Apatinib contraindications.
Patients of doctors considered unsuitable for the trial.

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

patients of gastric cancer in Henan province

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Suxia Luo	Henan Cancer Hospital	Principal Investigator
Peichun Sun	Henan Provincial People's Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Henan Cancer Hospital		Zhengzhou	Henan	450008	China

Condition Browse Module

MeSH Terms

ID	Term
D013274	Stomach Neoplasms

Ancestor Terms

ID	Term
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided