Gastric CarcinomaNCT03735511
A Real World Study of Apatinib in Treatment of Patients With Gastric Carcinoma
An observational study of Gastric Carcinoma, run by Henan Cancer Hospital at 1 site in China.
Trial summary
The study was designed to evaluate the efficacy and safety of apatinib in the treatment of patients with gastric carcinoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastric Carcinoma
- How many people
- 270 participants
- Where
- 1 siteChina
- Study dates
- 20 Nov 2018to Aug 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Chinese patients who were pathologically or cytologically diagnosed gastric carcinoma and treated by apatinib.
Who may be able to join
- Pathologically or cytologically confirmed gastric or residual gastric or gastroesophageal junction carcinoma;
- Patients received apatinib treatment at least once.
Who cannot join
- 1. No specific exclusion criteria in this real world study.
Trial locations and contacts
1 site in 1 country.
About this study
The study was designed to evaluate the efficacy and safety of apatinib in the treatment of patients with gastric carcinoma.
Read the 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.
- Conditions
- Gastric Carcinoma
- Medical subject headings
- Stomach Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival
Overall Survival
Measured: 2015-2018
Secondary outcomes (3)
Objective Response Rate
Objective Response Rate
Measured: 2015-2018
Disease Control Rate
Disease Control Rate
Measured: 2015-2018
Progression-Free Survival
Progression-Free Survival
Measured: 2015-2018
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2018
- Study start20 Nov 2018
- Primary completionAug 2020 (estimated)
- Study completionAug 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric CarcinomaStudies of the same condition, open and under way.
- More trials run by Henan Cancer HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 270 participants (actual)
Sponsor and investigators
- Lead sponsor
- Henan Cancer Hospital
- Sponsor type
- Other government
- Collaborators
- LinkDoc Technology (Beijing) Co. Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03735511
- Sponsor's protocol ID
- APA-GC-2018-HNZL
- Status last verified
- Apr 2020
- First submitted
- 7 Nov 2018
- Last updated
- 27 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Real World Study of Apatinib in Treatment of Patients With Gastric Carcinoma
- ClinicalTrials.gov ID
- NCT03735511
- Acronym / sponsor ID
- APA-GC-2018-HNZL
- Conditions
- Gastric Carcinoma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 270 participants (actual)
- Lead sponsor
- Henan Cancer HospitalOther government
- Collaborators
- LinkDoc Technology (Beijing) Co. Ltd.
- Study start
- 20 Nov 2018 (actual)
- Primary completion
- Aug 2020 (estimated)
- Study completion
- Aug 2020 (estimated)
- First posted
- 8 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Chinese patients who were pathologically or cytologically diagnosed gastric carcinoma and treated by apatinib.
Key inclusion criteria (2 listed)
- Pathologically or cytologically confirmed gastric or residual gastric or gastroesophageal junction carcinoma;
- Patients received apatinib treatment at least once.
Key exclusion criteria (1 listed)
- 1. No specific exclusion criteria in this real world study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Overall Survival
Time frame: 2015-2018
Overall Survival
3 secondary outcomes
Objective Response Rate
Time frame: 2015-2018
Disease Control Rate
Time frame: 2015-2018
Progression-Free Survival
Time frame: 2015-2018
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastric Carcinoma, run by Henan Cancer Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival (time frame: 2015-2018). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2020.