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

Sponsor
Henan Cancer Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT03735511
Collaborator
LinkDoc Technology (Beijing) Co. Ltd. (Industry)
270
Enrollment
1
Location
20.4
Anticipated Duration (Months)
13.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase

    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.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    270 participants
    Observational Model:
    Other
    Time Perspective:
    Retrospective
    Official Title:
    A Real World Study of Apatinib in Treatment of Patients With Gastric Carcinoma
    Actual Study Start Date :
    Nov 20, 2018
    Anticipated Primary Completion Date :
    Aug 1, 2020
    Anticipated Study Completion Date :
    Aug 1, 2020

    Outcome Measures

    Primary Outcome Measures

    1. Overall Survival [2015-2018]

      Overall Survival

    Secondary Outcome Measures

    1. Objective Response Rate [2015-2018]

      Objective Response Rate

    2. Disease Control Rate [2015-2018]

      Disease Control Rate

    3. Progression-Free Survival [2015-2018]

      Progression-Free Survival

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. Pathologically or cytologically confirmed gastric or residual gastric or gastroesophageal junction carcinoma;

    2. Patients received apatinib treatment at least once.

    Exclusion Criteria:
    1. No specific exclusion criteria in this real world study.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Henan Cancer Hospital Zhengzhou Henan China 450008

    Sponsors and Collaborators

    • Henan Cancer Hospital
    • LinkDoc Technology (Beijing) Co. Ltd.

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Henan Cancer Hospital
    ClinicalTrials.gov Identifier:
    NCT03735511
    Other Study ID Numbers:
    • APA-GC-2018-HNZL
    First Posted:
    Nov 8, 2018
    Last Update Posted:
    Apr 27, 2020
    Last Verified:
    Apr 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Carcinoma
    Stomach Neoplasms

    Study Results

    No Results Posted as of Apr 27, 2020