Condition or disease | Intervention/treatment | Phase |
---|---|---|
Advanced Gastric Cancer | Drug: Apatinib and PD1 | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 35 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Phase II Clinical Study of the Combination of Apatinib and PD1 in Treating Advanced Gastric Cancer |
Estimated Study Start Date : | June 1, 2019 |
Estimated Primary Completion Date : | June 1, 2021 |
Estimated Study Completion Date : | June 1, 2021 |
Arm | Intervention/treatment |
---|---|
Experimental: apatinib and PD-1
Every patients will received apatinib orally every day and PD-1 200mg (3mg/kg for underweight patients) iv every 2 weeks until disease progression or intolerance of side effect
|
Drug: Apatinib and PD1
|
Defined as the proportion of patients with a documented complete response, and partial response (CR
+ PR
Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Ning Li | 13526501903 | lining97@126.com |
Tracking Information | |||||
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First Submitted Date ICMJE | May 15, 2019 | ||||
First Posted Date ICMJE | May 17, 2019 | ||||
Last Update Posted Date | May 17, 2019 | ||||
Estimated Study Start Date ICMJE | June 1, 2019 | ||||
Estimated Primary Completion Date | June 1, 2021 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Overall survival rate [ Time Frame: up to 2 year ] | ||||
Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | No Changes Posted | ||||
Current Secondary Outcome Measures ICMJE |
|
||||
Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Exploratory Clinical Study of Apatinib and PD-1 in Treating Advanced Gastric Cancer | ||||
Official Title ICMJE | Phase II Clinical Study of the Combination of Apatinib and PD1 in Treating Advanced Gastric Cancer | ||||
Brief Summary | The Purpose of This Study is to Evaluate the Efficacy and Safety of Apafitini Combined With PD1 in Patients With Advanced Gastric Cancer After Second-line Treatment Failure, Thus Providing More Options for Patients With Advanced Gastric Cancer. | ||||
Detailed Description | Patients will received apatinib orally every day and PD-1 200mg (3mg/kg for underweight patients) iv every 2 weeks. The efficacy and safety will be observed. | ||||
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 |
||||
Condition ICMJE | Advanced Gastric Cancer | ||||
Intervention ICMJE | Drug: Apatinib and PD1
|
||||
Study Arms ICMJE | Experimental: apatinib and PD-1
Every patients will received apatinib orally every day and PD-1 200mg (3mg/kg for underweight patients) iv every 2 weeks until disease progression or intolerance of side effect
Intervention: Drug: Apatinib and PD1
|
||||
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 |
35 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Estimated Study Completion Date ICMJE | June 1, 2021 | ||||
Estimated Primary Completion Date | June 1, 2021 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
|
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Sex/Gender ICMJE |
|
||||
Ages ICMJE | 18 Years to 70 Years (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 | Not Provided | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT03954756 | ||||
Other Study ID Numbers ICMJE | APD-L0315 | ||||
Has Data Monitoring Committee | Not Provided | ||||
U.S. FDA-regulated Product |
|
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IPD Sharing Statement ICMJE | Not Provided | ||||
Responsible Party | Henan Cancer Hospital | ||||
Study Sponsor ICMJE | Henan Cancer Hospital | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE | Not Provided | ||||
PRS Account | Henan Cancer Hospital | ||||
Verification Date | May 2019 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |