Efficacy of Postoperative Adjuvant Treatments for Hepatocellular Carcinoma With Portal Vein Tumor Thrombosis
Recruitment status was Recruiting
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Purpose
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).
| Condition | Intervention |
|---|---|
|
Hepatocellular Carcinoma |
Other: PVIC, TACE |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Efficacy of Postoperative Adjuvant Treatments After Hepatectomy and Thrombectomy for Hepatocellular Carcinoma With Portal Vein Tumor Thrombosis |
- Overall Survival [ Time Frame: 1-year, 3-year, 5-year ] [ Designated as safety issue: No ]
- Time to Recurrence [ Time Frame: 1-year, 3-year, 5-year ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 260 |
| Study Start Date: | October 1999 |
| Estimated Study Completion Date: | December 2010 |
| Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
No Intervention: Control
Receive hepatectomy and thrombectomy alone, no postoperative adjuvant treatments
|
Other: PVIC, TACE
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. Other Names:
|
|
Experimental: PVIC Group
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.
|
Other: PVIC, TACE
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. Other Names:
|
|
Experimental: TACE Group
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.
|
Other: PVIC, TACE
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. Other Names:
|
|
Experimental: PVIC+TACE Group
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.
|
Other: PVIC, TACE
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. Other Names:
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Age 18 to 75 years
- Hepatocellular carcinoma with portal vein tumor thrombosis in the first branch and/or main trunk of the portal vein confirmed by preoperative radiologic investigations, intraoperative exploration and postoperative pathology.
- No extrahepatic metastasis
- No previous management
- The tumor and PVTT were completely removed confirmed by macroscopy and intraoperative ultrasonography
- Good or moderate hepatic function (Child-Pugh Class A or B)
- Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less
Exclusion Criteria:
- Refuse to participate
- Absolute neutrophil count <1.5*109/L, hemoglobin < 80g/L or platelet count <50 * 109/L, transaminases greater than 3 times the upper limit of normal, serum creatinine greater than 1.5 times the upper limit of normal, INR greater than 1.5 times of normal, which could not recover after treatment
- Ascites refractory to diuretics
- Variceal bleeding
- Severe diseases of the heart or Lung
Contacts and Locations| Contact: Xiaoying Wang, Doctor | 86-21-64041990 ext 2918 | xiaoyingwang@fudan.edu.cn |
| Contact: Jia Fan, Doctor | 86-21-64041990 ext 2375 | jiafan99@yahoo.com |
| China | |
| Liver Cancer Insitute, Zhongshan Hospital | Recruiting |
| Shanghai, China, 200032 | |
| Contact: Jia Fan, Doctor 86-21-64041990 ext 2375 jiafan99@yahoo.com | |
| Contact: Xiaoying Wang, Doctor 86-21-64041990 ext 2918 xiaoyingwang@fudan.edu.cn | |
| Principal Investigator: Jia Fan, Doctor | |
| Study Chair: | Jia Fan, Doctor | Zhongshan Hospital |
More Information
No publications provided
| Responsible Party: | Jia Fan, Liver Cancer Institute, Zhongshan Hospital |
| ClinicalTrials.gov Identifier: | NCT01033578 History of Changes |
| Other Study ID Numbers: | Fudan-LCI-PVTT-1 |
| Study First Received: | December 15, 2009 |
| Last Updated: | December 15, 2009 |
| Health Authority: | China: Food and Drug Administration |
Additional relevant MeSH terms:
|
Carcinoma Thrombosis Carcinoma, Hepatocellular Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Embolism and Thrombosis Vascular Diseases Cardiovascular Diseases Adenocarcinoma Liver Neoplasms Digestive System Neoplasms Neoplasms by Site |
Digestive System Diseases Liver Diseases Adjuvants, Immunologic Fluorouracil Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antimetabolites Molecular Mechanisms of Pharmacological Action Antimetabolites, Antineoplastic Antineoplastic Agents Therapeutic Uses Immunosuppressive Agents |
ClinicalTrials.gov processed this record on May 19, 2013