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The efficacy and safety of the PARP inhibitor in combination with the VEGFR inhibitor will be investigated in advanced refractory solid tumors patients with TP53 mutation .
TP53 is a well-known tumor suppressor gene. Multiple studies have demonstrated that TP53 mutations are poor prognostic factor in advanced solid tumor, the TP53 gene is frequently inactivated by mutation in a majority of human tumors. However, no effective TP53 -based therapy has been successfully translated into clinical cancer treatment. So, investigators intend to review and evaluate the efficacy and safety of the PARP inhibitor in combination with the VEGFR inhibitor for TP53 mutation in advanced refractory solid tumors patients from a real-world population.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Advanced refractory tumor solid tumors patients | Patients with advanced refractory solid tumors carrying TP53 mutations and receive PARP-inhibitors in combination with the VEGFR-inhibitors therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Data Collection | Other | Colleciton of data from medical records only |
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| Measure | Description | Time Frame |
|---|---|---|
| ORR(Objective Response Rate) | ORR is the percentage of participants with best overall response of complete response (CR), partial response (PR). Response categories: CR, PR, SD (stable disease), PD (progressive disease) Criteria on which physicians determined therapy response also will be captured by using Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.1 to evaluate. | Up to three months |
| Measure | Description | Time Frame |
|---|---|---|
| PFS (Progression Free Survival), calculated from various time points | Progression-free survival (PFS) is defined as progression free survival of all the evaluable participants who receive targeted drug therapy. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1). | Up to two years |
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Inclusion Criteria:
Exclusion Criteria:
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The objective is to describe in a real-world population.First of all, this study will be carried out as a retrospective, observational review of patients who clinically diagnosed as advanced refractory solid tumors received PARP-inhibitors combined with VEGFR-inhibitors drug therapy, from January 01, 2016 to August 01, 2018. The TP53 gene status must confirm by NGS (Next Generation Sequencing). Then, the investigators prospective observation effectiveness and safety of PARP-inhibitors combined with VEGFR-inhibitors therapy for patients who clinically diagnosed as advanced refractory solid tumors according to the inclusion and exclusion criteria. Those patients should have a NGS report to show the TP53 gene status.
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| Name | Affiliation | Role |
|---|---|---|
| Haitao Wang | Tianjin Medical Unversity Second Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tianjin Medical Unversity Second Hospital | Tianjin | Tianjin Municipality | 300211 | China |
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| ID | Term |
|---|---|
| D003625 | Data Collection |
| ID | Term |
|---|---|
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
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| OS (Overall Survival), calculated from various time points |
OS is defined as time from initiation to death of any cause. |
| Duration of time from the start of treatment to date of death, assessed up to two years |
| ADR (Adverse Drug Reaction) | Adverse events determined according to CTCAE (version 4.03). | 30 days after last dose |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |