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This is a phase II clinical study to evaluate the efficacy and safety of SIRT in patients with HCC greater than 7 cm. After enrollment, patients received yttrium-90 selective internal radiation therapy. The primary endpoint of the study is objective reponse rate (ORR) as assessed by mRECIST. Secondary endpoints were: objective response rate (ORR) as assessed by RECIST 1.1, disease control rate (DCR), progression-free survival (PFS), time to response (TTR), duration of response (DOR), overall survival (OS), and safety (incidence and severity of adverse events).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SIRT | Experimental | Patients will receive SIRT treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SIRT | Procedure | The patients will receive 1-2 sessions of SIRT. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate (ORR) per mRECIST | The proportion of patients with the best response of complete response (CR) or partial response (PR) according to mRECIST | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate (ORR) per RECIST 1.1 | The proportion of patients with the best response of complete response (CR) or partial response (PR) according to RECIST 1.1 | 3 years |
| Disease control rate (DCR) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mingyue Cai, Dr. | Contact | +86-20-34156205 | cai020@yeah.net | |
| Kangshun Zhu, Dr. | Contact | +86-20-34156205 | zhksh010@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second Affiliated Hospital of Guangzhou Medical University | Not yet recruiting | Guangzhou | Guangdong | 510260 | 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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| ID | Term |
|---|---|
| D037761 | Sirtuins |
| ID | Term |
|---|---|
| D056545 | Group III Histone Deacetylases |
| D006655 | Histone Deacetylases |
| D000581 | Amidohydrolases |
| D006867 | Hydrolases |
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The proportion of patients with the best response of CR, PR, or stable disease (SD) according to mRECIST and RECIST 1.1
| 3 years |
| Progression free survival (PFS) | The time from date of treatment initiation until the first occurrence of disease progression (according to mRECIST and RECIST 1.1) or death due to any cause, whichever occurs first. | 3 years |
| time to response (TTR) | The time from treatment initiation to first tumour remission (mRECIST and RECIST 1.1) | 3 years |
| Duration of response (DOR) | Time from first tumor response to first disease progression (mRECIST and RECIST 1.1 assessment) or death from any cause (whichever occurs first) | 3 years |
| Overall survival (OS) | The time from date of treatment initiation to death due to any cause | 4 years |
| Adverse Events (AEs) | Number of patients with AEs assessed by Common Terminology Criteria for Adverse Events v5.0 | 3 years |
| The Second Affiliated Hospital of Guangzhou Medical University | Recruiting | Guangzhou | Guangdong | 510260 | China |
|
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
| D004798 |
| Enzymes |
| D045762 | Enzymes and Coenzymes |
| D036002 | ADP Ribose Transferases |
| D010430 | Pentosyltransferases |
| D016695 | Glycosyltransferases |
| D014166 | Transferases |
| D047908 | Intracellular Signaling Peptides and Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |