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Hepatocellular carcinoma (HCC) is the sixth most common malignancies worldwide and the second leading cause of cancer-related death. Surgical resection is still the main radical approach for HCC, but the recurrence rate after hepatectomy is very high, which hampers the further improvement of prognosis of HCC patients. The conventional risk factors of recurrence including: huge tumor, multiple lesions, vessels invasion and tumor rupture. Recently, the microvessels invasion (MVI) has been recognized a novel risk factor of recurrence after hepatectomy. The investigators' previous study showed that the recurrence rate is more than 50% for the patients with >5cm solitary tumor and MVI. The MVI was confirmed as the only independent risk factor for the overall and disease-free survival of HCC patients in multiple variables analysis. It is important to reduce the recurrence and prolong the survival of patients after hepatectomy with effective adjuvant therapy. TACE has been utilized as an adjuvant therapy after hepatectomy, but its significance is still unknown. Then, the investigators design the current prospective randomized clinical trial to evaluate the effect of adjuvant TACE to reduce the recurrence in HCC patients at high risk (>5cm solitary tumor and MVI) after resection, compared to vigilant follow-up.
The patients with solitary tumor more than 5cm and microvessels invasion after radical hepatectomy were randomized to receive adjuvant TACE(1~2 cycles, 4~6 weeks) or follow-up. The main endpoint: overall survival (OS), disease-free survival(DFS), and safety were compared between this two groups.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adjuvant TACE | Experimental | Adjuvant TACE were performed 4-6 weeks after surgery |
|
| Follow-up | Other | Routine follow-up were performed instead of adjuvant TACE |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adjuvant TACE | Procedure | 1~2 cycles TACE were performed as adjuvant therapy after radical hepatectomy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | The overall survival is defined as the percentage of patients who are alive at 5 years after their enrollments of this study. | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Disease-free survival | The disease-free survival is defined as the percentage of patients who are alive at 5 years without any signs or symptoms of HCC after their enrollments of this study. | 5 years |
| Safety: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rong-ping GUO, 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 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19408012 | Background | Zhong C, Guo RP, Li JQ, Shi M, Wei W, Chen MS, Zhang YQ. A randomized controlled trial of hepatectomy with adjuvant transcatheter arterial chemoembolization versus hepatectomy alone for Stage III A hepatocellular carcinoma. J Cancer Res Clin Oncol. 2009 Oct;135(10):1437-45. doi: 10.1007/s00432-009-0588-2. Epub 2009 May 1. | |
| 7895595 |
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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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| Follow-up | Procedure | Patients received just follow-up to monitor the recurrence of HCC |
|
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 |
| 5 years |
| Li JQ, Zhang YQ, Zhang WZ. [Evaluation of chemoembolization as an adjuvant therapy for primary liver carcinoma after surgical resection]. Zhonghua Zhong Liu Za Zhi. 1994 Sep;16(5):387-9. Chinese. |
| 7541051 | Background | Li JQ, Zhang YQ, Zhang WZ, Yuan YF, Li GH. Randomized study of chemoembolization as an adjuvant therapy for primary liver carcinoma after hepatectomy. J Cancer Res Clin Oncol. 1995;121(6):364-6. doi: 10.1007/BF01225689. |
| 16795984 | Background | Peng B, Liang L, He Q, Zhou F, Luo S. Surgical treatment for hepatocellular carcinoma with portal vein tumor thrombus. Hepatogastroenterology. 2006 May-Jun;53(69):415-9. |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |