A Phase 4 interventional study of Preoprative TACE and Liver resection plus Thrombectomy in Resectable Hepatocellular Carcinoma With Portal Vein Tumor Thrombus, sponsored by Sun Yat-sen University. Completed at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2019-03-07.
Sponsored by Sun Yat-sen University · Phase 4, Interventional, and Treatment
Whether preoperative transarterial chemoembolization can prolong survival for the resectable hepatocellular carcinoma remains controversial, particularly in patients with portal vein tumor thrombi. This study designs to systematically identify and summarize the effect of preoperative TACE for resectable HCC with portal venous invasion.
With various improvements in interventional radiology, since the 2005 practice guidelines issued by the American Association for the Study of Liver Diseases , transcatheter arterial chemoembolization has become one of the available locoregional therapies for HCC. Transcatheter arterial chemoembolization, which generally performed in intermediate-stage HCC patients, involves injection of an embolizing agent into the hepatic artery to deprive the tumor of its major nutrient source via embolization of the nutrient artery, resulting in ischemic necrosis of the tumor. To prevent intrahepatic recurrence due to portal vein invasion of the HCC tumor, therapeutic strategies such as preoperative TACE, and postoperative adjuvant chemotherapy have been tried. According to the latest and the most powerful evidence, however, preoperative TACE is not routinely recommended for patients undergoing hepatectomy to treat resectable HCC , and TACE may delay surgical treatment or decrease the resection volume of the liver, or it also may create a missed opportunity for surgical treatment.
Rather than subject all these patients to such an invasive procedure and put them at risk for missing opportunity for surgical treatment, it may be better to select optimal candidates to receive surgical resection. Recent studies have even shown favorable long-term survival outcomes of HR in well-selected cases of HCC with PVTT. About whether preoperative transarterial chemoembolization is available for the resectable hepatocellular carcinoma with portal vein tumor thrombi, so far, has hardly been reported.
3,249 studies on the registry are indexed under Carcinoma, Hepatocellular; 974 are open to participants now.
This study's enrollment of 330 is above the median of 55 across 2,347 interventional studies indexed under Carcinoma, Hepatocellular.
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In the preoperative TACE arm (Arm 2), patients underwent TACE followed by surgical resection. Preoperative TACE sessions were repeated once at 4-week intervals unless patients showed either PD or PVTT PD. Then, the patients were prepared for surgical resection, with the exception of those with unresectable disease after TACE For patients who had unresectable disease after TACE, plans for surgical resection were abandoned and the subsequent treatment course was determined by his/her attending oncologist
Procedure: Preoprative TACE · Procedure: Liver resection plus Thrombectomy
Liver resection Plus Thrombectomy
Procedure: Liver resection plus Thrombectomy
Also known as: Preoperative transarterial chemoembolization
Liver resection plus Thrombectomy
Also known as: Removal of all tumor tissue by surgery
overall survival time
Time frame: 5years
disease free survival
Time frame: 5 years
Number of Adverse Events
All severe adverse events for the entire course of treatment, including treatment for primary tumor and recurrent tumor.
Time frame: 30 days
The record gives a start of Feb 2006, a primary completion of Aug 2013 and a completion of Aug 2013. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.
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