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Yttrium-90 (y90) Microsphere Injection Solution was approved by the NMPA in 2022. Currently, there is a lack of summary of real-world data in China. Therefore, this retrospective real-world study is intented to explore the characteristics and efficacy of HCC patients treated with y90 in China, aiming to provide reference for guiding and optimizing clinical practices and subsequent confirmatory clinical studies for the treatment of HCC patients in China.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| adult HCC patients treated with yttrium90 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Yttrium-90 (Y-90) resin microspheres | Device | selective internal radiation therapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| best hepatic ORR measured by mRECIST criteria | 6 months following y90 therapy |
| Measure | Description | Time Frame |
|---|---|---|
| ORR measured by mRECIST criteria | 6 months following y90 therapy | |
| OS | From date of first Y90 therapy until the date of death from any cause, assessed up to 24 months | |
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Inclusion Criteria:
Exclusion Criteria:
no formal exclusion criteria in a real-world study
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adult HCC patients treated with yttrium-90 during 2023.1.1 - 2024.6.30 and assessed at least once for tumor response within 6 months following treatment
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| Name | Affiliation | Role |
|---|---|---|
| Xiaobin Feng, MD | Beijing Tsinghua Changgeng Hospital | Principal Investigator |
| Kangshun Zhu, MD | Second Affiliated Hospital of Guangzhou Medical University | Principal Investigator |
| Yefa Yang, MD | Eastern Hepatobiliary Surgery Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second Affiliated Hospital of Guangzhou Medical University | Guangzhou | Guangdong | China | |||
| The First Affiliated Hospital of Jinan University |
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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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| TTP |
time to progression |
| From date of first Y90 therapy until the date of first documented progression, assessed up to 24 months |
| PFS | From date of first Y90 therapy until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months |
| Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 | 6 months following y90 therapy |
| Jinan |
| Guangdong |
| China |
| Xi'An International Medical Center Hospital | Xi’an | Guangxi | China |
| No.1 Affiliated Hospital of Xian Jiaotong University | Xi’an | Shanxi | China |
| Beijing Tsinghua Changgung Hospital | Beijing | China |
| The Third Affiliated Hospital of Naval Medical University | Shanghai | China |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |