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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03629691
Enrollment
187
Registered
2018-08-14
Start date
2015-02-01
Completion date
2018-05-19
Last updated
2018-08-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastric Cancer Metastatic to Lung, Lung Cancer

Keywords

Cavitation, PFS

Brief summary

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.

Detailed description

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.

Interventions

OTHERlung cavitation

apatinib treated patients developed lung cavitation

Sponsors

The Affiliated Hospital of Qingdao University
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

Inclusion criteria

1. Between February 1, 2015 and May 19, 2018, 433 adult patients with gastric adenocarcinoma, lung adenocarcinoma and lung squamous cell carcinoma 2. Multiline chemotherapy failure and lack of standard treatment, received oral apatinib 250 mg daily at the Affiliated Hospital of Qingdao University. 3. Histologically proven were identified retrospectively using the Clinical Research Information Systems (CRIS) database. 4. 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

1. Cardiac disease and hemorrhagic disease were excluded. 2. Patients with lung cavitation before apatinib treated.

Design outcomes

Primary

MeasureTime frameDescription
PFS (progression-free survival)From February 1, 2015 to May 19, 2018 ,about 27 monthsEvaluation 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

MeasureTime frameDescription
LRC (duration of locoregional control )From February 1, 2015 to May 19, 2018 , about 27 monthsFor metastatic lung cancer, LRC is the local control of metastatic lung tumor here.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 2, 2026