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Hepatocellular carcinoma (HCC) patients is a common disease in the East Asia. Although resection was recommend for early stage (BCLC A stage) patients according to the BCLC (Barcelona clinical liver cancer) system, increasing studies suggested that preoperative transarterial therapy may decrease the recurrence risk for those with high-risk factors. However, the clinical value is still undertermined. Recently, FOLFOX (Oxaliplatin and 5-fluorouracil) based hepatic artery infusion chemotherapy (HAIC) exhibited high response rate for unresectable HCC. Pilot study showed TACE combined HAIC (TACE-HAIC) had better tumor response, with low progression disease rate. Whether TACE-HAIC would improve survival for BCLC A stage patients with high-risk factors is need to further to study. A randomized clinical trial compared neo-TACE-HAIC with surgery versus surgery alone is aimed to answer this question.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| neo-TACE-HAIC with surgery | Experimental | transartery chemoembolization with lipiodol and EADM, FOLFOX (Oxa 85mg/m2 2h+CF 400mg/m2 2h+5FU 400mg/m2 10min+5FU 1200mg/m2 23h)-based artery infusion chemotherapy, followed by hepatic resection |
|
| surgery alone | Active Comparator | hepatic resection remove the liver tumors |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| neo-TACE-HAIC+Surgery | Procedure | transartery chemoembolization with lipiodol and EADM, FOLFOX (Oxa 85mg/m2 2h+CF 400mg/m2 2h +5FU 400mg/m2 10min+5FU 1200mg/m2 23h)-based artery infusion chemotherapy, followed by hepatic resection |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival, PFS | PFS was calculated from the date of starting treatment to the date of progression, of disease or death | 36 months |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival, OS | OS was calculated from the date of starting treatment to the date of death. | 60 months |
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Inclusion Criteria:
Exclusion Criteria:
• With unresectable HCC
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jiliang Qiu | Contact | 862087343114 | qiujl@sysucc.org.cn | |
| Xuzhi Pan | Contact | 862087343009 | panxzh@sysucc.org.cn |
| Name | Affiliation | Role |
|---|---|---|
| Yunfei Yuan | Sun Yat-sen University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun Yat-sen University Cancer Center | Recruiting | Guangzhou | Guangdong | 510060 | 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 |
|---|---|
| D013514 | Surgical Procedures, Operative |
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| Surgery alone | Procedure | hepatic resection remove the liver tumors |
|
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |