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The standard treatment choice for advanced hepatocellular carcinoma (HCC) is sorafenib, and its efficacy is limited. More active treatments were performed in patients with advanced HCC in China, which include radical hepatectomy or TACE. The study is to investigate whether the active treatment will profit survival of patients, and to evaluate the safety.
This is a prospective non-randomized controlled study. Patients with advanced hepatocellular carcinoma (BCLC C stage) who underwent palliative resection or TACE followed with Sorafenib or treated by sorafenib alone will be included. The patients will be divided to group A (palliative resection plus sorafenib), group B (palliative TACE plus sorafenib), and group C (sorafenib alone). The sample size will be about 200 cases altogether.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A, surgery | Experimental | The patients in this group will receive palliative resection of HCC, then take sorafenib as remain therapy. |
|
| B, TACE | Experimental | Patients in group B will receive transcatheter hepatic arterial chemoembolization, then take sorafenib as remain therapy. |
|
| C, sorafenib | Experimental | Patients in group C will receive monotherapy of sorafenib. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| hepatic resection | Procedure | palliative hepatectomy followed by sorafenib |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival (OS) | defined as the time from the first treatment to death | anticipate 6-12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival (PFS) | defined as the time from the first treatment to the first progression disease is confirmed by radiological methods | anticipate 3-6 months |
| AEs and SAEs | according to CTC AE 3.0 |
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Inclusion Criteria:
Definition of resectable in this study:
Platelet count > 60 x 109/L Hemoglobin > 8.5 g/dL Albumin > 3.5 g/dL Total bilirubin < 25μmol/L Alanine transaminase (ALT) and AST < 2.5 x upper limit of normal Serum creatinine <1.5 x the upper limit of normal Prothrombin time (PT)<3 seconds above control.
• Patients who give written informed consent.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Minshan Chen, M.D. | Sun Yat-Sen University Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun Yat-sen University Cancer Center | 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 |
|---|---|
| D006498 | Hepatectomy |
| D000077157 | Sorafenib |
| ID | Term |
|---|---|
| D013505 | Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D010671 | Phenylurea Compounds |
| D014508 | Urea |
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| transcatheter hepatic arterial chemoembolization | Procedure | TACE followed by sorafenib |
|
|
| sorafenib | Drug | sorafenib monotherapy, 400mg Bid, continuously |
|
|
| anticipate 6-12 months |
| cost of treatments | to compare costs of different treatments | 3 months in average |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| 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 |