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This study seeks to evaluate the clinical value of the personalized therapy model with the guidance of Molecular Tumor Board (MTB) after Next Generation Sequencing(NGS), and to track patient outcomes.
This is a study from the real world. Advanced refractory solid tumors patients with no standard treatment options have a very poor prognosis. In recent years, the application of s Next Generation Sequencing (NGS) has rapidly expanded the breadth and depth of understanding of the molecular mechanism of tumors, laying a foundation for the development of precision medicine for tumors. Researchers can build a molecular phenotype of advanced refractory solid tumors by NGS. Some retrospective study shows that Molecular Tumor Board (MTB) therapy model brings therapeutic hope. So, investigators hope that this therapy model combined with NGS may provide treatment recommendations for advanced refractory solid tumors patients. Those recommendations may include some off-label targeted therapies. This study seeks to evaluate the clinical value of the personalized therapy model with the guidance of MTB after NGS, and to track patient outcomes, including ORR (Objective Response Rate), PFS (Progression Free Survival), OS (Overall Survival) and ADR (Adverse Drug Reaction).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Personalized therapy model with Molecular Tumor Board and Next Generation Sequencing | Other | This study is to observe this therapy model outcomes |
|
| 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:
1.According to the investigator' judgment, there are serious, uncontrollable risks to patients' safety, or associated diseases (such as severe diabetes, thyroid disease, infection, spinal cord compression, superior vena cava syndrome, neurological or psychiatric disorders and so on) that affect the patients completion of the study.
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The objective is to describe in a real-world advanced refractory solid tumors 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 personalized therapy with the guidance of MTB (molecular tumor board) after the NGS (next generation sequencing). Then, the investigators prospective observation personalized therapy plan which the MTB recommends for patients who clinically diagnosed as advanced refractory solid tumors according to the inclusion and exclusion criteria.
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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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| 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 2 years |
| ADR (Adverse Drug Reaction) | Adverse events determined according to CTCAE (version 4.03). | 30 days after last dose. |
| ID | Term |
|---|---|
| D059014 | High-Throughput Nucleotide Sequencing |
| ID | Term |
|---|---|
| D017421 | Sequence Analysis |
| D005821 | Genetic Techniques |
| D008919 | Investigative Techniques |
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