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The purpose of this study is to evaluate the efficacy and safety of sorafenib combined with hepatic arterial infusion chemotherapy (HAIC) compared with lenvatinib combined with HAIC in patients with advanced hepatocellular carcinoma (HCC)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HAIC plus Lenvatinib | Experimental |
| |
| HAIC plus Sorafenib | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lenvatinib | Drug | 12 mg (or 8 mg) once daily (QD) oral dosing. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | Overall survival | Time Frame: 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Time to progression | Time to progression | Time Frame: 12 months |
| Adverse Events | [Time Frame: 30 days] | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ming Shi, MD | Contact | +862087343938 | shiming@sysucc.org.cn |
| Name | Affiliation | Role |
|---|---|---|
| Ming Shi, MD | Sun Yat-sen University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cancer Center Sun Yat-sen University | 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 |
|---|---|
| C531958 | lenvatinib |
| D000077157 | Sorafenib |
| ID | Term |
|---|---|
| D010671 | Phenylurea Compounds |
| D014508 | Urea |
| D000577 | Amides |
| D009930 | Organic Chemicals |
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| Sorafenib |
| Drug |
400mg BID daily oral dosing |
|
| Hepatic arterial infusion chemotherapy | Procedure | administration of Oxaliplatin , fluorouracil, and leucovorin via the tumor feeding arteries |
|
| Progression Free Survival (PFS) |
| Time Frame: 12 months |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
| D001555 |
| Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009536 | Niacinamide |
| D009539 | Nicotinic Acids |
| D000147 | Acids, Heterocyclic |
| D006571 | Heterocyclic Compounds |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |