Advanced Refractory Solid Tumors With TP53 Mutations Register Study
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|ClinicalTrials.gov Identifier: NCT03927599|
Recruitment Status : Enrolling by invitation
First Posted : April 25, 2019
Last Update Posted : August 20, 2019
|Condition or disease||Intervention/treatment|
|Solid Tumor, Adult||Other: Data Collection|
|Study Type :||Observational|
|Actual Enrollment :||100 participants|
|Official Title:||Prospective and Retrospective Register Study of PARP-Inhibitors Combined With VEGFR-Inhibitors for Treatment of Advanced Refractory Solid Tumors Patients With TP53 Mutations|
|Actual Study Start Date :||August 1, 2018|
|Estimated Primary Completion Date :||December 31, 2019|
|Estimated Study Completion Date :||January 31, 2020|
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
Other: Data Collection
Colleciton of data from medical records only
- ORR(Objective Response Rate) [ Time Frame: Up to three months ]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.
- PFS (Progression Free Survival), calculated from various time points [ Time Frame: Up to two years ]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).
- OS (Overall Survival), calculated from various time points [ Time Frame: Duration of time from the start of treatment to date of death, assessed up to two years ]OS is defined as time from initiation to death of any cause.
- ADR (Adverse Drug Reaction) [ Time Frame: 30 days after last dose ]Adverse events determined according to CTCAE (version 4.03).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03927599
|Tianjin Medical Unversity Second Hospital|
|Tianjin, Tianjin, China, 300211|
|Principal Investigator:||Haitao Wang||Tianjin Medical Unversity Second Hospital|