Personalized Therapy of Molecular Tumor Board Participation With the Guidance of Next Generation Sequencing
|ClinicalTrials.gov Identifier: NCT03929653|
Recruitment Status : Enrolling by invitation
First Posted : April 29, 2019
Last Update Posted : April 29, 2019
|Condition or disease||Intervention/treatment|
|Solid Tumor, Adult||Other: Personalized therapy model with Molecular Tumor Board and Next Generation Sequencing|
|Study Type :||Observational|
|Estimated Enrollment :||500 participants|
|Official Title:||Prospective and Retrospective Register Study of Personalized Therapy of Molecular Tumor Board Participation With The Guidance of Next Generation Sequencing|
|Actual Study Start Date :||June 1, 2017|
|Estimated Primary Completion Date :||June 30, 2019|
|Estimated Study Completion Date :||December 31, 2019|
Advanced Refractory Solid Tumors
Patients with advanced refractory solid tumors receive personalized therapy with the guidance of Molecular Tumor Board after the NGS(next generation sequencing).
Other: Personalized therapy model with Molecular Tumor Board and Next Generation Sequencing
This study is to observe this therapy model outcomes
- 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 2 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).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03929653
|Tianjin Medical Unversity Second Hospital|
|Tianjin, Tianjin, China, 300211|
|Principal Investigator:||Haitao Wang||Tianjin Medical Unversity Second Hospital|