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

Gastric Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03333967
• Other study ID #: AHAT-104
• Status: Recruiting
• Phase: N/A
• First received: October 1, 2017
• Last updated: November 6, 2017
• Start date: September 1, 2017
• Est. completion date: September 1, 2020

Study information

• Verified date: September 2017
• Source: The First Affiliated Hospital of Anhui Medical University
• Contact: guoping sun, doctor
• Phone: 0551-62922249
• Email: gpsun_ahmu[@]126.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: September 1, 2020
• Est. primary completion date: September 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Male or female patients .

2. Confirmed by Pathology or histology of Gastric cancer

3. Patients should be voluntary to the trial and provide with signed informed consent

4. The researchers believe patients can benefit from the study.

Exclusion Criteria:

1. Patients with a known history of allergic reactions and/or hypersensitivity attributed to apatinib or its accessories

2. Pregnant or lactating women

3. Patients with Apatinib contraindications

4. Patients of doctors considered unsuitable for the trial

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Locations

Country	Name	City	State
China	First Affiliated Hospital of Anhui Medical University	Hefei	Anhui

Sponsors (1)

Lead Sponsor	Collaborator
The First Affiliated Hospital of Anhui Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Quality of life score	Quality of life score is a questionnaire developed to assess the quality of life of cancer patients.	1year
Other	adverse events	adverse events are evaluated according to National Cancer Institute Common Terminology Criteria for Adverse Events v4.0.	1year
Primary	Progress free survival	Progress free survival is defined as the length of time from random assignment to disease progression or to death resulting from any cause other than the progress.	1 year
Secondary	disease control rate	Investigators will assess treatment response according to Response Evaluation Criteria in Solid Tumors 1.1	1year
Secondary	Objective tumor response rate	Objective tumor response rate is defined as the percentage of subjects having achieved confirmed Complete Response + Partial Response as best overall response according to radiological assessments	1year
Secondary	overall survival	overall survival is defined as the length of time from random assignment to death or to last contact.	3year
Secondary	Disease-free survival	Disease-free survival is defined as the length of time from the date of randomization to the date of first documentation of relapse of gastric cancer or any other type of cancer or death.	1 year