A Real World Study of Apatinib in Treatment of Patients W... | NCT03735511

Studies
A Real World Study of Apatinib in Treatment of Patients With Gastric Carcinoma

NCT03735511

Sponsor

Henan Cancer Hospital

Status

Unknown status

Last Update Posted

Apr 27, 2020Actual

Enrollment

270Actual

Phase

Not provided

Conditions

Gastric Carcinoma

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

Apr 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

Nov 20, 2018Actual

Primary Completion Date

Aug 2020Estimated

Completion Date

Aug 2020Estimated

First Submitted Date

Nov 7, 2018

First Submission Date that Met QC Criteria

Nov 7, 2018

First Posted Date

Nov 8, 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

Apr 23, 2020

Last Update Posted Date

Apr 27, 2020Actual

Name	Class
LinkDoc Technology (Beijing) Co. Ltd.	INDUSTRY

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 study was designed to evaluate the efficacy and safety of apatinib in the treatment of patients with gastric carcinoma.

Detailed Description

The study is a real-world non-interventional retrospective study and will collect the original medical records of patients with gastric carcinoma treated with apatinib from 2015 to 2018 in Henan Cancer Hospital. Clinical data such as patient demographic, history of treatments, tumor biological characteristics and adverse events will be analyzed to evaluate the efficacy and safety of apatinib and explore the risk factors of prognosis in patients with gastric carcinoma.

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

270Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Overall Survival	Overall Survival	2015-2018

Secondary Outcomes

Measure	Description	Time Frame
Objective Response Rate	Objective Response Rate	2015-2018
Disease Control Rate	Disease Control Rate	2015-2018

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Pathologically or cytologically confirmed gastric or residual gastric or gastroesophageal junction carcinoma;
Patients received apatinib treatment at least once.

Exclusion Criteria:

1. No specific exclusion criteria in this real world study.

Accepts Healthy Volunteers

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

Chinese patients who were pathologically or cytologically diagnosed gastric carcinoma and treated by apatinib.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

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

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

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