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The aim of this study is to assess efficacy of the different adjuvant chemotherapy strategies after hepatectomy and thrombectomy for hepatocellular carcinoma (HCC) and portal vein tumor thrombosis( PVTT).
Hepatocellular carcinoma (HCC) is the sixth most common cancer worldwide and the third major cause of cancer-related death. HCC is characterized by its propensity for portal vein invasion. Portal vein tumor thrombosis (PVTT) can be detected macroscopically in the portal vein in 44% to 62.2% of autopsy cases. The natural history of untreated HCC with PVTT is dismal. The median survival of such patients was reported to be 2.7 mouths.
Non-surgical therapies, such as systemic/regional chemotherapy and transcatheter arterial embolization / transcatheter arterial chemoembolization (TAE/TACE), are not effective in treating HCC with PVTT. With the improvement of surgical techniques, surgical resection has been reported to achieve promising results. However, the high rate of recurrence and metastasis constitutes one of the most important challenges in improving surgical efficacy for HCC with PVTT.
There is rare report about prevention and treatment of postoperative recurrence and metastasis for HCC with macroscopical PVTT patients. We previously found the postoperative portal vein infusion chemotherapy (PVIC) and TACE benefited PVTT patients, which required further prospective randomized controlled studies with large case number to support our findings. The randomized controlled trial was design to investigate the efficacy of the different adjuvant chemotherapy strategies after hepatectomy and thrombectomy for HCC and PVTT.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | No Intervention | Receive hepatectomy and thrombectomy alone, no postoperative adjuvant treatments |
|
| PVIC Group | Experimental | Portal Vein Infusion Chemotherapy (PVIC): 5-fluorouracil (650 mg/m2 for 24 hours on days 1), doxorubicin (10 mg/m2 for 6 hours on days 2), and cisplatin (20 mg/m2 for 6 hours on days 3) was continuously infused into portal vein through tube by a infusion pump implanted in operation. Treatment started 2 weeks after the operation and was repeated every 4 weeks for six cycles. |
|
| TACE Group | Experimental | Transcatheter Arterial Chemoembolization (TACE): 5-fluorouracil (650 mg/m2), doxorubicin (10 mg/m2), cisplatin (20 mg/m2), and lipiodol 5ml were injected into hepatic artery by puncturing the common femoral artery in the right groin and passing a catheter through the abdominal aorta, through the celiac axis and common hepatic artery, into the proper hepatic artery. Treatment started 4 weeks after the operation and was repeated at 6-8 weeks intervals for 3 cycles. |
|
| PVIC+TACE Group | Experimental | Combination of PVIC and TACE. PVIC started 2 weeks after operation and TACE started 6 weeks after operation. Both PVIC and TACE were repeated at 8 weeks intervals for 3 cycles. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PVIC, TACE | Other | PVIC:5-fluorouracil (650 mg/m2 for 24 hours on days 1), doxorubicin (10 mg/m2 for 6 hours on days 2), and cisplatin (20 mg/m2 for 6 hours on days 3) were continuously infused into portal vein through tube by a infusion pump. Treatment started 2 weeks after the operation and was repeated every 4 weeks for 6 cycles. TACE: 5-fluorouracil (650 mg/m2), doxorubicin (10 mg/m2), cisplatin (20 mg/m2), and lipiodol 5ml were injected into hepatic artery by puncturing the common femoral artery in the right groin and passing a catheter through the abdominal aorta, through the celiac axis and common hepatic artery, into the proper hepatic artery. Treatment started 4 weeks after the operation and was repeated at 6-8 weeks intervals for 3 cycles. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | 1-year, 3-year, 5-year |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Recurrence | 1-year, 3-year, 5-year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiaoying Wang, Doctor | Contact | 86-21-64041990 | 2918 | xiaoyingwang@fudan.edu.cn |
| Jia Fan, Doctor | Contact | 86-21-64041990 | 2375 | jiafan99@yahoo.com |
| Name | Affiliation | Role |
|---|---|---|
| Jia Fan, Doctor | Shanghai Zhongshan Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Liver Cancer Insitute, Zhongshan Hospital | Recruiting | Shanghai | 200032 | 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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|
|
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |