Condition or disease | Intervention/treatment | Phase |
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HER-2 Negatived Gastric Cancer | Drug: Apatinib and S-1 | Phase 2 |
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 Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 30 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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) |
Actual Study Start Date : | July 1, 2017 |
Estimated Primary Completion Date : | July 1, 2019 |
Estimated Study Completion Date : | July 1, 2020 |
Arm | Intervention/treatment |
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Experimental: Apatinib and S1 group
Combined with Apatinib (250mg qd po) and S-1 (40-60mg bid d1-14) as maintenance therapy in advanced HER-2 negatived GC
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Drug: Apatinib and S-1
Combined with Apatinib (250mg qd po) and S-1 (40-60mg bid d1-14) as maintenance therapy in advanced HER-2 negatived GC
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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
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 ;
Exclusion Criteria:
Contact: Yingying Huang | 86-10-85136715 | yinghh@hotmail.com |
China, Beijing | |
Beijing Hospital | Recruiting |
Beijing, Beijing, China, 100730 | |
Contact: Yingying Huang 86-10-85136715 yinghh@hotmail.com |
Principal Investigator: | yingying Huang | Beijing Hospital |
Tracking Information | |||||
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First Submitted Date ICMJE | November 18, 2018 | ||||
First Posted Date ICMJE | May 15, 2019 | ||||
Last Update Posted Date | May 15, 2019 | ||||
Actual Study Start Date ICMJE | July 1, 2017 | ||||
Estimated Primary Completion Date | July 1, 2019 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
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.
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | No Changes Posted | ||||
Current Secondary Outcome Measures ICMJE |
overall survival [ Time Frame: Patients will be followed for an average period of 1 year ] From date of registration until the date of death from any cause or the last follow-up visit.
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Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Pre-specified Outcome Measures |
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Original Other Pre-specified Outcome Measures | Same as current | ||||
Descriptive Information | |||||
Brief Title ICMJE | Apatinib Combined With S-1 as Maintenance Therapy for HER-2 Negatived Gastric Cancer | ||||
Official Title ICMJE | Apatinib Combined With S-1 as Maintenance Therapy for HER-2 Negatived Gastric Cancer Treated With 4 Cycles Chemotherapy Valued as Stable Disease (SD) | ||||
Brief 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 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. |
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Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 2 | ||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | HER-2 Negatived Gastric Cancer | ||||
Intervention ICMJE | Drug: Apatinib and S-1
Combined with Apatinib (250mg qd po) and S-1 (40-60mg bid d1-14) as maintenance therapy in advanced HER-2 negatived GC
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Study Arms ICMJE | Experimental: Apatinib and S1 group
Combined with Apatinib (250mg qd po) and S-1 (40-60mg bid d1-14) as maintenance therapy in advanced HER-2 negatived GC
Intervention: Drug: Apatinib and S-1
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Unknown status | ||||
Estimated Enrollment ICMJE |
30 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Estimated Study Completion Date ICMJE | July 1, 2020 | ||||
Estimated Primary Completion Date | July 1, 2019 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | China | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT03950141 | ||||
Other Study ID Numbers ICMJE | 2017BJYYH-053-02 | ||||
Has Data Monitoring Committee | Yes | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Yingying Huang, Beijing Hospital | ||||
Study Sponsor ICMJE | Beijing Hospital | ||||
Collaborators ICMJE | Jiangsu HengRui Medicine Co., Ltd. | ||||
Investigators ICMJE |
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PRS Account | Beijing Hospital | ||||
Verification Date | May 2019 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |