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A real-world study of FGF19 overexpression status and treatment outcome and prognosis in advanced hepatocellular carcinoma
This is a real-world, single-arm, observational study to collect information on the diagnosis and prognosis of hepatocellular carcinoma patients with previous tissue samples in routine clinical practice, and to detect the expression of FGF19 expression in tissue samples, with a view to discovering prognostic and predictive markers for advanced hepatocellular carcinoma The treatment protocol of this study follows the clinical practice and does not set any limitations on the interventions for patients.
In this study, real-world liver tissue samples will be collected from patients with hepatocellular liver cancer after surgical resection, and the samples will be sent to a third-party pathology slice reviewer for review, and a report on the FGF19 expression results will be returned to the project team. Simultaneously collect clinical data of the patient.
According to the principle of clinical routine diagnosis and treatment, the patient's imaging data were collected, and the imaging of the 2-month period was evaluated, and whether the disease progressed was judged according to the RESCIST v1.1 standard. Every two months will be an observation cycle. Each subject will be followed from the first treatment until disease progression or change of drug regimen.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| inspection team | Surgically resected liver tissue samples were sent to a third-party pathology slice reviewer for uniform reading, and a report on FGF19 expression results was issued and returned to the project team. The clinical data of the patient will be collected at the same time. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Other | This is an observational study and does not involve an intervention |
|
| Measure | Description | Time Frame |
|---|---|---|
| PFS | PFS was calculated from the date of randomization to the date of the first documented disease progression, with no time constraints involved, marked by the appearance of disease progression | Enrollment until disease progression |
| OS | Observation until death from the beginning of participation in the study observation until death from any cause, no time frame limitations were involved. Calculation of OS based on time of death | Start of enrollment until death (from any cause) |
| Measure | Description | Time Frame |
|---|---|---|
| ORR | Proportion of patients whose tumor volume shrinks to a preset value and remains unchanged for a given period of time, total study duration 36 months, ORR observation period within 36 months | Time to enrollment until disease downsizing |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with HCC in the middle to late stages of the diseaseï¼›Sufficient previous hepatocellular carcinoma tissue samples were available for immunohistochemical detection of FGF19
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| ZHAOYING Resident physician, phD | Contact | 86+13810943515 | zya03937@btch.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| ZHAOYING Resident physician, phD | Beijing Tsinghua Changgeng Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Tsinghua Changgung Hospital | Beijing | China |
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| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |