Gastric CancerNCT03478943
The Real World Study of Apatinib for Gastric Cancer Treatment in Henan Province
An observational study of Gastric Cancer, run by Henan Cancer Hospital at 1 site in China.
Trial summary
The investigators conduct the real world study to explore the efficacy and safety of Apatinib in gastric cancer . Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastric Cancer
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- 30 Jan 2016to 1 Dec 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
- Adult, Older adult
Study population: patients of gastric cancer in Henan province
Who may be able to join
- Male or female patients .
- Confirmed by Pathology or histology of Gastric cancer.
- Patients should be voluntary to the trial and provide with signed informed consent.
- The researchers believe patients can benefit from the study.
Who cannot join
- Patients with a known history of allergic reactions and/or hypersensitivity attributed to apatinib or its accessories.
- Pregnant or lactating women.
- Patients with Apatinib contraindications.
- Patients of doctors considered unsuitable for the trial.
Trial locations and contacts
1 site in 1 country.
About this study
The investigators conduct the real world study to explore the efficacy and safety of Apatinib in gastric cancer .
- Conditions
- Gastric Cancer
- Medical subject headings
- Stomach Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Progress free survival
Measured: 1 year
Disease-free surviva
Measured: 1 year
Secondary outcomes (3)
overall survival
Measured: 3 year
Objective Response Rate
Measured: 1 year
Disease Control Rate
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2018
- Study start30 Jan 2016
- Primary completion1 Aug 2020 (estimated)
- Study completion1 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric CancerStudies 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
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Henan Cancer Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Suxia Luo, Principal investigator, Henan Cancer HospitalPeichun Sun, Principal investigator, Henan Provincial People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03478943
- Sponsor's protocol ID
- Ahead-HAT01
- Status last verified
- May 2020
- First submitted
- 20 Mar 2018
- Last updated
- 28 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Real World Study of Apatinib for Gastric Cancer Treatment in Henan Province
- ClinicalTrials.gov ID
- NCT03478943
- Acronym / sponsor ID
- Ahead-HAT01
- Conditions
- Gastric Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Henan Cancer HospitalOther government
- Study start
- 30 Jan 2016 (actual)
- Primary completion
- 1 Aug 2020 (estimated)
- Study completion
- 1 Dec 2020 (estimated)
- First posted
- 27 Mar 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 investigators conduct the real world study to explore the efficacy and safety of Apatinib in gastric cancer .
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- patients of gastric cancer in Henan province
Key inclusion criteria (4 listed)
- Male or female patients .
- Confirmed by Pathology or histology of Gastric cancer.
- Patients should be voluntary to the trial and provide with signed informed consent.
- The researchers believe patients can benefit from the study.
Key exclusion criteria (4 listed)
- Patients with a known history of allergic reactions and/or hypersensitivity attributed to apatinib or its accessories.
- Pregnant or lactating women.
- Patients with Apatinib contraindications.
- Patients of doctors considered unsuitable for the trial.
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
Progress free survival
Time frame: 1 year
Disease-free surviva
Time frame: 1 year
3 secondary outcomes
overall survival
Time frame: 3 year
Objective Response Rate
Time frame: 1 year
Disease Control Rate
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2020.
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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.
Suxia Luo principal investigator
Henan Cancer Hospital
Peichun Sun principal investigator
Henan Provincial People's Hospital
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 Cancer, 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 4 inclusion and 4 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 28 May 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?
Progress free survival (time frame: 1 year). The study lists 2 primary outcomes in all. 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 28 May 2020.