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To assess 1-year recurrence-free survival (RFS) in patients with hepatocellular carcinoma (HCC) who are at high risk of Inguinal orchiectomy recurrence usingTACE combined with icaritin
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TACE combination with icaritin | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TACE combined with Acoradine | Drug | Transcatheter hepatic arterial chemoembolization (TACE) : the treatment interval was 28 days, the window period was ± 7 days. Subjects received a maximum of 4 TACE treatments; reduced and delayed treatment: laboratory tests were performed before the start of each cycle of TACE, with investigator criteria confirming whether TACE treatment was feasible. Acoradine: 6 tablets bid, taken after meals for 6 months or until intolerable or progressive disease (starting one month after surgery) . |
| Measure | Description | Time Frame |
|---|---|---|
| 1 year recurrence-free survival rate ,1-year RFSR. | 1 year recurrence-free survival rate ,1-year RFSR. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| TTR( time to recurrence) | TTR( time to recurrence) | 1year |
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Inclusion Criteria:
The subjects voluntarily cooperated with the study and signed the informed consent,
Male or female, 18 years old ≤ age ≤75 years old,
The histopathologic diagnosis was hepatocellular carcinoma
R0 resection was performed within 4 to 8 weeks before recruitment (patients who were confirmed to have R0 resection by imaging and pathological examination were excluded from the study group if the residual R1, residual R2 or the margin of resection were not clear)
To satisfy any of the following high risk factors for postoperative recurrence of hepatocellular carcinoma:
I) BCLC stage B (> 3 tumors, regardless of size or number, at least one of which is > 3 cm in diameter) ; ii) single tumor ≥5 cm in diameter; III) intraoperative or postoperative pathological findings of vascular invasion (including microvascular invasion and VP1/VP2 portal vein invasion) ; IV) histopathologic grade of low differentiation; v) capsular invasion or loss with unclear border; VI) direct invasion of adjacent organs
ECOG performance status score of 0-1 and Child-Pugh score of 5-6
None of the patients had received anti-tumor therapy for hepatocellular carcinoma, including systemic therapy and local therapy (except for 1-2 prophylactic TACE or HAIC 4-8 weeks after radical therapy) .
Subjects who received radical therapy, if required, were allowed to receive 1-2 prophylactic TACE/Haic treatments 4-8 weeks after surgery (on demand and not necessarily)
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shunjun Fu Fu Shunjun Fu, Prof. | Contact | 15989187352 | fsj103@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhujiang Hospital, Southern Medical University | Recruiting | Guangzhou | Guangdong | 510000 | 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 |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
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