Two Different Treatment MethodsPhase 2NCT03334591
Research On the Optimized Treatment Method For Apatinib's Cure Of Advanced Gastric Cancer
A Phase 2 study testing Apatinib in people with Two Different Treatment Methods, run by Anhui Provincial Hospital at 1 site in China.
Trial summary
The investigators hope that after this research, two different treatment methods' curative effects for advanced gastric cancer can be assessed. One is continuous use of apatinib, the other is 5 days' continuous use and 2 days' off of apatinib. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Two Different Treatment Methods
- What is being tested?
- Apatinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2017to 1 Dec 2019
- Phase
- Phase 2
- 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
Who may be able to join
- Male and female patients,age≥18years
- Confirmed by Pathology or histology of Gastric cancer
- Patients who failed first-line chemotherapy
- The ECOG physical status score:0 to 2
- Expected survival ≥3months
- Patients should be voluntary to the trail and provide with signed informed consent.
- The researchers believe patients can benefit from the study.
Who cannot join
- Pregnant or lactating women
- Patients with a knowm history of allergic reactions and/ou hypersensitivity attributed to apatinib or its accessories
- Patients with apatinib contraindications
- Patients of doctors considered unsuitable for the trail
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Anhui Provincial Cancer Hospital
Hefei, Anhui, 230000
yifu he, doctor, 0551-65327666, 834638033@qq.com
About this study
The investigators hope that after this research, two different treatment methods' curative effects for advanced gastric cancer can be assessed. One is continuous use of apatinib, the other is 5 days' continuous use and 2 days' off of apatinib.
- Conditions
- Two Different Treatment Methods
- Being tested
- Apatinib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ApatinibDrug
Apatinib 500mg with Docetaxel 60mg/m2
| Study group | Role | What they receive |
|---|---|---|
| Apatinib 5 days' continuous use and 2 days' off | Experimental | Apatinib 500mg 5 days' continuous use and 2 days' off with Docetaxel60mg/m2 to treat advanced gastric cancer Receives: Drug: Apatinib |
| Apatinib 500mg continuous use | Active comparator | Apatinib 500mg continuous use with Docetaxel60mg/m2 to treat advanced gastric cancer Receives: Drug: Apatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
progress free survival(PFS)
From data of randomization until the date of first dccumentde progression or date of death from any cause
Measured: 1 year
Secondary outcomes (5)
disease control rate (DCR)
investigators will assess treatment response according to Response Evaluation Criteria in Soid Tumor
Measured: 1year
Objective tumor response rate(ORR)
difined as the percentage of subjects having achieved confirmed Complete Response+Partial Response as best overall response according to radiological assessments
Measured: 1year
overall survival (os)
difined as the length of time from random assignment to death or to last contact
Measured: 1year
Quality of life score
a questionnaire developed to assess the quality of life of cancer patients
Measured: 1 year
adverse events
adverse events are evaluated according to National Cancer institute Common Terminology Criteria for Adverse Events
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 Oct 2017
- Primary completion1 Oct 2019 (estimated)
- Study completion1 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Two Different Treatment MethodsStudies 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Anhui Provincial Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- yifu He, doctor, Study chair, Anhui Provincial Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03334591
- Sponsor's protocol ID
- HYF001
- Status last verified
- Oct 2017
- First submitted
- 3 Nov 2017
- Last updated
- 14 Nov 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Yan Y, Li H, Wu S, Wang G, Luo H, Niu J, Cao L, Hu X, Xu H, Jia W, Sun Y, Yao Y, Chen W, Ke L, Hu B, Ji C, Sun Y, Chen J, Li M, He Y. Efficacy and safety of intermittent versus continuous dose apatinib plus docetaxel as second-line therapy in patients with advanced gastric cancer or gastroesophageal junction adenocarcinoma: a randomized controlled study. Ann Transl Med. 2022 Feb;10(4):205. doi: 10.21037/atm-22-546.
PubMed 35280426
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Research On the Optimized Treatment Method For Apatinib's Cure Of Advanced Gastric Cancer
- ClinicalTrials.gov ID
- NCT03334591
- Acronym / sponsor ID
- HYF001
- Conditions
- Two Different Treatment Methods
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Anhui Provincial HospitalOther government
- Study start
- 1 Oct 2017 (actual)
- Primary completion
- 1 Oct 2019 (estimated)
- Study completion
- 1 Dec 2019 (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 hope that after this research, two different treatment methods' curative effects for advanced gastric cancer can be assessed. One is continuous use of apatinib, the other is 5 days' continuous use and 2 days' off of apatinib.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Apatinib 5 days' continuous use and 2 days' off | Experimental | Drug: ApatinibApatinib 500mg 5 days' continuous use and 2 days' off with Docetaxel60mg/m2 to treat advanced gastric cancer |
| Apatinib 500mg continuous use | Active comparator | Drug: ApatinibApatinib 500mg continuous use with Docetaxel60mg/m2 to treat advanced gastric cancer |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male and female patients,age≥18years
- Confirmed by Pathology or histology of Gastric cancer
- Patients who failed first-line chemotherapy
- The ECOG physical status score:0 to 2
- Expected survival ≥3months
Key exclusion criteria (4 listed)
- Pregnant or lactating women
- Patients with a knowm history of allergic reactions and/ou hypersensitivity attributed to apatinib or its accessories
- Patients with apatinib contraindications
- Patients of doctors considered unsuitable for the trail
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ApatinibApatinib 500mg with Docetaxel 60mg/m2 | Drug | Apatinib 5 days' continuous use and 2 days' off, Apatinib 500mg continuous use |
Primary outcome
progress free survival(PFS)
Time frame: 1 year
From data of randomization until the date of first dccumentde progression or date of death from any cause
5 secondary outcomes
disease control rate (DCR)
Time frame: 1year
Objective tumor response rate(ORR)
Time frame: 1year
overall survival (os)
Time frame: 1year
Quality of life score
Time frame: 1 year
adverse events
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 14 Nov 2017.
- Derived from this study: PubMed 35280426Yan Y, Li H, Wu S, Wang G, Luo H, Niu J, Cao L, Hu X, Xu H, Jia W, Sun Y, Yao Y, Chen W, Ke L, Hu B, Ji C, Sun Y, Chen J, Li M, He Y. Efficacy and safety of intermittent versus continuous dose apatinib plus docetaxel as second-line therapy in patients with advanced gastric cancer or gastroesophageal junction adenocarcinoma: a randomized controlled study. Ann Transl Med. 2022 Feb;10(4):205. doi: 10.21037/atm-22-546.
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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.
yifu He, doctor study chair
Anhui Provincial Cancer Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Apatinib in people with Two Different Treatment Methods, run by Anhui Provincial 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 7 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 14 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 yifu He, doctor (0551-65327666, 834638033@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
progress free survival(PFS) (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 NCT03334591, which also lists 1 linked publication.
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 14 Nov 2017.