HER-2 Negatived Gastric CancerPhase 2NCT03950141
Apatinib Combined With S-1 as Maintenance Therapy for HER-2 Negatived Gastric Cancer
A Phase 2 study testing Apatinib and S-1 in people with HER-2 Negatived Gastric Cancer, run by Beijing Hospital at 1 site in China.
Trial summary
Apatinib is a novel drug which was produced by Jiangsu Hengrui Medicine Co.Ltd in China. It is approved in advanced gastric cancer（GC）. The investigators just want to design such kind of trail to prove its effect when combined with S-1 as maintenance in advanced HER-2 negatived GC treated with 4 cycles chemotherapy… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HER-2 Negatived Gastric Cancer
- What is being tested?
- Apatinib and S-1
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2017to 1 Jul 2020
- 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
- Histologically proved advanced HER-2 negatived gastric adenocarcinoma;
- At least a unresectable factor before operation via CT, MRI, or PET-CT: difficult resection of locally advanced gastric cancer(T4b); hepatic metastasis (H1; at most five lesions, total diameter ≤8 cm); Peritoneal metastasis(CY1, P1) ; Definitely diagnosed as unresectable GC via exploratory laparoscopy or laparotomy;
- ECOG performance status 0-2;
- Age≥ 18 years old, Life expectancy estimated than 3 months;
- For results of blood routine test and biochemical tests:
- Hgb ≥ 80g/L, WBC ≥ 4000/mm3, ANC ≥ 1.5×109/L, platelets ≥ 80×109/L ALT and AST ≤ 2.5 x upper normal limit (UNL), and ≤ 5 x UNL（Hematogenous metastases）, Serum Total bilirubin ≤ 1.5 X UNL, Serum Creatine ≤ 1.5 x UNL ；
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- Good cardiac function before the recruitment, no seizure of myocardial infarction in past half years, and controllable hypertension and other coronary heart disease;
- Not concomitant with other uncontrollable benign disease before the recruitment(e.g. the infection in the kidney, lung and liver);
- Informed consent.
Who cannot join
- Subjects with poor-controlled arterial hypertension (systolic blood pressure> 140 mmHg and diastolic blood pressure > 90 mm Hg) despite standard medical management;
- Coronary heart disease greater than Class I; I-level arrhythmia (including QT interval prolongation, for man ≥ 450 ms, for woman ≥ 470 ms) together with Class I cardiac dysfunction;
- Patients with positive urinary protein;
- Factors that could have an effect on oral medication (such as inability to swallow, chronic diarrhea and intestinal obstruction);
- Subjects with high gastrointestinal bleeding risk, including the following conditions: local active ulcer lesions with positive fecal occult blood test (++); history of black stool, or vomiting blood in the past 2 months;
- Contraindications include allergy to apatinib and/or its accessories, active bleeding, intestinal perforation, intestinal obstruction, within 30 days after surgery, drugs with poor-controlled hypertension, Class Ⅲ-Ⅳ cardiac dysfunction （NYHA standard）, severe hepatic and renal dysfunction（level 4）if apatinib use is considered;
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- Abnormal Coagulation (INR>1.5, APTT>1.5 UNL), with tendency of bleed;
- Pregnant or lactating women; Any other condition that might place the patient at undue risk or preclude a patient from completing the study;
- Treated with 4 cycles chemotherapy included Tegafur;
- Other conditions regimented at investigators' discretion.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Hospital
Beijing, Beijing Municipality, 100730
Yingying Huang, 86-10-85136715, yinghh@hotmail.com
About this study
Official title: Apatinib Combined With S-1 as Maintenance Therapy for HER-2 Negatived Gastric Cancer Treated With 4 Cycles Chemotherapy Valued as Stable Disease (SD)
Apatinib is a novel drug which was produced by Jiangsu Hengrui Medicine Co.Ltd in China. It is approved in advanced gastric cancer（GC）. The investigators just want to design such kind of trail to prove its effect when combined with S-1 as maintenance in advanced HER-2 negatived GC treated with 4 cycles chemotherapy and valued as SD. Investigators will evaluate progression free survival (PFS) and overall survival (OS).
Read the detailed description
GC is the second most common cause of cancer-related deaths worldwide. Most patients are diagnosed with unresectable advanced or metastatic stage disease losing the radical surgery opportunity. Till now there is no novel targeted drug which can increase the OS for advanced GC patients except HER-2 positive patients.
Approximate 30 patients with unresectable GC treated with 4 cycles chemotherapy and valued as stable disease will be enrolled in this study,The investigators will evaluate the efficacy and security of apatinib and S-1 as maintenance therapy.
- Conditions
- HER-2 Negatived Gastric Cancer
- Being tested
- Apatinib and S-1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Apatinib and S-1Drug
Combined with Apatinib (250mg qd po) and S-1 (40-60mg bid d1-14) as maintenance therapy in advanced HER-2 negatived GC
| Study group | Role | What they receive |
|---|---|---|
| Apatinib and S1 group | Experimental | Combined with Apatinib (250mg qd po) and S-1 (40-60mg bid d1-14) as maintenance therapy in advanced HER-2 negatived GC Receives: Drug: Apatinib and S-1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
progression-free survival
From date of registration until the date of disease progresssion or death resulting from any cause.
Measured: Patients will be followed for an average period of 1 year
Secondary outcomes (1)
overall survival
From date of registration until the date of death from any cause or the last follow-up visit.
Measured: Patients will be followed for an average period of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2019
- Study start1 Jul 2017
- Primary completion1 Jul 2019 (estimated)
- Study completion1 Jul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HER-2 Negatived 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Hospital
- Sponsor type
- Other government
- Collaborators
- Jiangsu HengRui Medicine Co., Ltd.
- Responsible party
- Principal investigator, Yingying Huang, Beijing Hospital
- Investigators
- yingying Huang, Principal investigator, Beijing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03950141
- Sponsor's protocol ID
- 2017BJYYH-053-02
- Status last verified
- May 2019
- First submitted
- 18 Nov 2018
- Last updated
- 15 May 2019
- Results posted
- No
- Data monitoring committee
- Yes
- 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 15 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Apatinib Combined With S-1 as Maintenance Therapy for HER-2 Negatived Gastric Cancer Treated With 4 Cycles Chemotherapy Valued as Stable Disease (SD)
- ClinicalTrials.gov ID
- NCT03950141
- Acronym / sponsor ID
- 2017BJYYH-053-02
- Conditions
- HER-2 Negatived Gastric Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Beijing HospitalOther government
- Collaborators
- Jiangsu HengRui Medicine Co., Ltd.
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 1 Jul 2019 (estimated)
- Study completion
- 1 Jul 2020 (estimated)
- First posted
- 15 May 2019 (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.
Apatinib is a novel drug which was produced by Jiangsu Hengrui Medicine Co.Ltd in China. It is approved in advanced gastric cancer（GC）. The investigators just want to design such kind of trail to prove its effect when combined with S-1 as maintenance in advanced HER-2 negatived GC treated with 4 cycles chemotherapy and valued as SD. Investigators will evaluate progression free survival (PFS) and overall survival (OS).
Detailed description
GC is the second most common cause of cancer-related deaths worldwide. Most patients are diagnosed with unresectable advanced or metastatic stage disease losing the radical surgery opportunity. Till now there is no novel targeted drug which can increase the OS for advanced GC patients except HER-2 positive patients.
Approximate 30 patients with unresectable GC treated with 4 cycles chemotherapy and valued as stable disease will be enrolled in this study,The investigators will evaluate the efficacy and security of apatinib and S-1 as maintenance therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Apatinib and S1 group | Experimental | Drug: Apatinib and S-1Combined with Apatinib (250mg qd po) and S-1 (40-60mg bid d1-14) as maintenance therapy in advanced HER-2 negatived GC |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Histologically proved advanced HER-2 negatived gastric adenocarcinoma;
- At least a unresectable factor before operation via CT, MRI, or PET-CT: difficult resection of locally advanced gastric cancer(T4b); hepatic metastasis (H1; at most five lesions, total diameter ≤8 cm); Peritoneal metastasis(CY1, P1) ; Definitely diagnosed as unresectable GC via exploratory laparoscopy or laparotomy;
- ECOG performance status 0-2;
- Age≥ 18 years old, Life expectancy estimated than 3 months;
- For results of blood routine test and biochemical tests:
Key exclusion criteria (10 listed)
- Subjects with poor-controlled arterial hypertension (systolic blood pressure> 140 mmHg and diastolic blood pressure > 90 mm Hg) despite standard medical management;
- Coronary heart disease greater than Class I; I-level arrhythmia (including QT interval prolongation, for man ≥ 450 ms, for woman ≥ 470 ms) together with Class I cardiac dysfunction;
- Patients with positive urinary protein;
- Factors that could have an effect on oral medication (such as inability to swallow, chronic diarrhea and intestinal obstruction);
- Subjects with high gastrointestinal bleeding risk, including the following conditions: local active ulcer lesions with positive fecal occult blood test (++); history of black stool, or vomiting blood in the past 2 months;
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 |
|---|---|---|
| Apatinib and S-1Combined with Apatinib (250mg qd po) and S-1 (40-60mg bid d1-14) as maintenance therapy in advanced HER-2 negatived GC | Drug | Apatinib and S1 group |
Primary outcome
progression-free survival
Time frame: Patients will be followed for an average period of 1 year
From date of registration until the date of disease progresssion or death resulting from any cause.
1 secondary outcome
overall survival
Time frame: Patients will be followed for an average period of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2019.
- Individual participant dataSharing planned: No
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.
yingying Huang principal investigator
Beijing 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 and S-1 in people with HER-2 Negatived Gastric Cancer, run by Beijing 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 9 inclusion and 10 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 15 May 2019. 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 Yingying Huang (86-10-85136715, yinghh@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
progression-free survival (time frame: Patients will be followed for an average period of 1 year). 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 15 May 2019.