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Completed

NCT Number: NCT03629691

Study for Patients With Lung Metastatic Advanced Gastric Cancer and NSCLC Treated With Apatinib

The primary end point was progression-free survival (PFS), secondary end points included duration of locoregional control (LRC), overall survival (OS), quality of life and safety. For metastatic lung cancer, LRC is the local control of metastatic lung tumor here.

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Key information

About this study

Between February 1, 2015 and May 19, 2018, 433 adult patients with gastric adenocarcinoma, lung adenocarcinoma and lung squamous cell carcinoma, multiline chemotherapy failure and lack of standard treatment, received oral apatinib 250 mg daily at the Affiliated Hospital of Qingdao University. Histologically proven were identified retrospectively using the Clinical Research Information Systems (CRIS) database. All patients were with Karnofsky performance status ≥70% or an Eastern Cooperative Oncology Group performance status of 0 to 1, with stable hepatic, hematologic, and renal functions. Cardiac disease and hemorrhagic disease were excluded. All patients had pre-therapy chest computed tomography (CT) prior to apatinib treatment, and follow-up chest CT at least every 4 weeks. The primary end point was progression-free survival (PFS), secondary end points included duration of locoregional control (LRC), overall survival (OS), quality of life and safety. For metastatic lung cancer, LRC is the local control of metastatic lung tumor here. Other patient demographic and clinical data, including age, gender; stage of disease, apatinib administered inclusion and withdrawal date, adverse events, oncologic clinical response, comorbid conditions, and smoking history, were retrieved from the CRIS database.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Between February 1, 2015 and May 19, 2018, 433 adult patients with gastric adenocarcinoma, lung adenocarcinoma and lung squamous cell carcinoma
  • Multiline chemotherapy failure and lack of standard treatment, received oral apatinib 250 mg daily at the Affiliated Hospital of Qingdao University.
  • Histologically proven were identified retrospectively using the Clinical Research Information Systems (CRIS) database.
  • All patients were with Karnofsky performance status over 70% or an Eastern Cooperative Oncology Group performance status of 0 to 1, with stable hepatic, hematologic, and renal functions.

Exclusion criteria

  • Cardiac disease and hemorrhagic disease were excluded.
  • Patients with lung cavitation before apatinib treated.

Treatment and study plan

lung cavitation

Other

apatinib treated patients developed lung cavitation

Primary outcomes

  1. PFS (progression-free survival)

    Time frame: From February 1, 2015 to May 19, 2018 ,about 27 months

    Evaluation of the oncologic clinical response was based on the alternate, modified method. We concluded that incorporating an assessment of cavitation when measuring target lesions might more accurately reflect changes in tumor volume. It was used for target lesions in which the longest diameter of any cavitation (zero if no cavity presented) was subtracted from the longest total diameter of the lesion, with each measurement taken in the same plane, to provide an alternate measure that was used to calculate the sum of measurements for all target lesions.

Secondary outcomes

  1. LRC (duration of locoregional control )

    Time frame: From February 1, 2015 to May 19, 2018 , about 27 months

    For metastatic lung cancer, LRC is the local control of metastatic lung tumor here.

Sponsors and collaborators

Lead sponsor

The Affiliated Hospital of Qingdao University

Other

Registry information

Official study title

A Retrospective Study for Patients With Lung Metastatic Advanced Gastric Cancer or NSCLC Treated With Apatinib

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Aug 14, 2018
Registry last updated
Aug 16, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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