Gastric CancerNCT03333967
The Real World Study of Apatinib for Gastric Cancer Treatment in Anhui Province
An observational study of Gastric Cancer, run by The First Affiliated Hospital of Anhui Medical University 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
- 1 Sep 2017to 1 Sep 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: patients of gastric cancer in Anhui 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.
China1 site, 1 recruiting
- Recruiting
First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, 230000
Guoping Sun, doctor, 0551-62922249, gps_anmu@126.com
About this study
The investigators conduct the real world study to explore the efficacy and safety of Apatinib in gastric cancer .
- Conditions
- Gastric Cancer
- Keywords
- apatinib
- 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
Progress free survival is defined as the length of time from random assignment to disease progression or to death resulting from any cause other than the progress.
Measured: 1 year
Secondary outcomes (4)
disease control rate
Investigators will assess treatment response according to Response Evaluation Criteria in Solid Tumors 1.1
Measured: 1year
Objective tumor response rate
Objective tumor response rate is defined as the percentage of subjects having achieved confirmed Complete Response + Partial Response as best overall response according to radiological assessments
Measured: 1year
overall survival
overall survival is defined as the length of time from random assignment to death or to last contact.
Measured: 3year
Disease-free survival
Disease-free survival is defined as the length of time from the date of randomization to the date of first documentation of relapse of gastric cancer or any other type of cancer or death.
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 posted7 Nov 2017
- Study start1 Sep 2017
- Primary completion1 Sep 2019 (estimated)
- Study completion1 Sep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital of Anhui Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- China Anhui, Study chair, The First Affiliated Hospital of Anhui Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03333967
- Sponsor's protocol ID
- AHAT-104
- Status last verified
- Sep 2017
- First submitted
- 1 Oct 2017
- Last updated
- 7 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Peng W, Zhang F, Wang Z, Li D, He Y, Ning Z, Sheng L, Wang J, Xia X, Yu C, Wang Z, Zhao Y, Liang H, Hu B, Sun C, Wang D, Cheng Y, Pan M, Xia L, Guo X, Zhang Y, Hu Z, Li X, Lu L, Zhang J, Qian H, Xie H, Sun G. Large Scale, Multicenter, Prospective Study of Apatinib in Advanced Gastric Cancer: A Real-World Study from China. Cancer Manag Res. 2020 Aug 6;12:6977-6985. doi: 10.2147/CMAR.S249153. eCollection 2020.
PubMed 32821164Du Y, Cao Q, Jiang C, Liang H, Ning Z, Ji C, Wang J, Zhou C, Jiang Z, Yu C, Li L, Zhao Y, Xu Y, Xu T, Hu W, Wang D, Cheng H, Wang G, Zhou J, Wang S, Zhang Y, Hu Z, Li X, Lu D, Zhang J, Xie H, Sun G. Effectiveness and safety of low-dose apatinib in advanced gastric cancer: A real-world study. Cancer Med. 2020 Jul;9(14):5008-5014. doi: 10.1002/cam4.3105. Epub 2020 May 22.
PubMed 32441892
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2017. 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 Anhui Province
- ClinicalTrials.gov ID
- NCT03333967
- Acronym / sponsor ID
- AHAT-104
- Conditions
- Gastric Cancer
- Keywords
- apatinib
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Anhui Medical UniversityUniversity, hospital or other
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 1 Sep 2019 (estimated)
- Study completion
- 1 Sep 2020 (estimated)
- First posted
- 7 Nov 2017 (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
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients of gastric cancer in Anhui 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
Progress free survival is defined as the length of time from random assignment to disease progression or to death resulting from any cause other than the progress.
4 secondary outcomes
disease control rate
Time frame: 1year
Objective tumor response rate
Time frame: 1year
overall survival
Time frame: 3year
Disease-free survival
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 7 Nov 2017.
- Derived from this study: PubMed 32821164Peng W, Zhang F, Wang Z, Li D, He Y, Ning Z, Sheng L, Wang J, Xia X, Yu C, Wang Z, Zhao Y, Liang H, Hu B, Sun C, Wang D, Cheng Y, Pan M, Xia L, Guo X, Zhang Y, Hu Z, Li X, Lu L, Zhang J, Qian H, Xie H, Sun G. Large Scale, Multicenter, Prospective Study of Apatinib in Advanced Gastric Cancer: A Real-World Study from China. Cancer Manag Res. 2020 Aug 6;12:6977-6985. doi: 10.2147/CMAR.S249153. eCollection 2020.
- Derived from this study: PubMed 32441892Du Y, Cao Q, Jiang C, Liang H, Ning Z, Ji C, Wang J, Zhou C, Jiang Z, Yu C, Li L, Zhao Y, Xu Y, Xu T, Hu W, Wang D, Cheng H, Wang G, Zhou J, Wang S, Zhang Y, Hu Z, Li X, Lu D, Zhang J, Xie H, Sun G. Effectiveness and safety of low-dose apatinib in advanced gastric cancer: A real-world study. Cancer Med. 2020 Jul;9(14):5008-5014. doi: 10.1002/cam4.3105. Epub 2020 May 22.
- Individual participant dataSharing planned: Yes
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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.
China Anhui study chair
The First Affiliated Hospital of Anhui Medical University
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 The First Affiliated Hospital of Anhui Medical University 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 7 Nov 2017. 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?
Contact guoping sun, doctor (0551-62922249, gpsun_ahmu@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progress free survival (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03333967, which also lists 2 linked publications.
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 7 Nov 2017.