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| Name | Class |
|---|---|
| Chinese PLA General Hospital | OTHER |
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This study intends to compare the efficacy of transcatheter arterial chemical embolization (TACE) with hepatic arterial infusion chemotherapy (HAIC) for patients with intermediate-advanced huge hepatocellular carcinoma.
Transcatheter arterial chemoembolization (TACE) and hepatic arterial infusion chemotherapy (HAIC) are effective and safe for hepatocellular carcinoma (HCC). For huge HCC (≥10 cm), the prognosis of this high tumor-burden subtype usually indicates poor outcome and big challenge. TACE is difficult to completely embolize all tumor arteries, so patients have limited benefit from pure hepatic artery embolization. At the same time, excessive embolization will lead to massive tumor necrosis in a short time, and inflammatory necrosis factor will enter the blood, resulting in systemic inflammatory response. HAIC have showed good efficacy especially for advanced huge HCC (≥10 cm) complicated with portal vein tumor thrombus and arteriovenous fistula, and HAIC therapy can be performed with better and higher tumor control.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TACE | TACE procedure was a 2.8-F microcatheter was super-selectively inserted into the tumor feeding artery using the coaxial technique. Then conventional TACE or drug-eluting TACE was used. |
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| HAIC | HIAC was conducted with hepatic arterial infusion of oxaliplatin, fluorouracil, and leucovorin every 3-4 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TACE | Procedure | TACE was carried out under the guidance of digital subtraction angiography, and hepatic artery angiography was used to assess the location, number, size, and blood supply of the targeted tumor. Then a more selective microcatheter was used to vascularize the tumor. The emulsion of the selected drug and the embolization agents was therefore injected infused into tumor-feeding arteries via the selective microcatheter. A final arteriography confirmed the success of the procedure. The endpoint of the TACE procedure was reached when there was no flow in the tumor-feeding vessels. |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate | ORR, as determined based on tumor response according to mRECIST, is defined as the proportion of all included patients whose best overall response (BOR) is either a complete response or partial response. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-Free-Survival | Progression was defined as progressive disease by independent radiologic review | 12 months |
| Overall survival | OS is the length of time from the date of inclusion until death from any cause. |
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Inclusion Criteria:
Exclusion Criteria:
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This study is a multicenter, observational real-world study to compare the efficacy of HAIC with TACE in advancedhuge hepatocellular carcinoma. This study focused on the management of locoregional therapy . This study will create a database that will provide clinical parameters and outcomes of patients undergoing HIAC and TACE in huge HCC therapy.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Qunfang Zhou, MD | Contact | 86 19868000115 | zhouqun988509@163.com | |
| Feng Duan, MD | Contact | 86 13910984586 | duanfeng@vip.sina.com |
| Name | Affiliation | Role |
|---|---|---|
| Feng Duan, MD | Chinese PLA General Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chinese PLA general hospital | Recruiting | Beijing | Beijing Municipality | 100853 | China |
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| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| D008113 | Liver Neoplasms |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| HAIC | Procedure | HAIC was carried out under the guidance of digital subtraction angiography, 990and hepatic artery angiography was used to assess the location, number, size, and blood supply of the targeted tumor. Then a more selective microcatheter was used to vascularize the tumor. The FOLFOX regimen was administered via the hepatic artery as follows: 85 or 135 mg/m2 oxaliplatin from hour 0 to 2 on day 1, and 400 mg/m2 leucovorin from hour 2 to 4 on day 1, and 400 mg/m2 fluorouracil bolus at hour 5 on the day 1; and 2400 mg/m2 fluorouracil over 46 h on days 1 and 2. Hepatic arterial infusion chemotherapy administration of oxaliplatin, fluorouracil, and leucovorin via the tumor feeding arteries every 4 weeks |
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| 24 months |
| D009369 | Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |