| 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 | |||||
|---|---|---|---|---|---|
| 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. |
|||||
| 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:
|
||||
| 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 |
|
||||
| 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 |
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