Preoperative Transarterial Chemoembolization for Resectable HCC With Portal Venous Invasion

Phase 4

Completed

• Conditions: Resectable Hepatocellular Carcinoma With Portal Vein Tumor Thrombus
• Interventions: Procedure: Preoprative TACE; Procedure: Liver resection plus Thrombectomy

• Registration Number: NCT01952353
• Lead Sponsor: Sun Yat-sen University

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2006-02
• Primary Completion: 2013-08
• Study Completion: 2013-08
• Study First Submitted: 2013-09-24
• Study First Submitted QC: 2013-09-24
• Study First Posted: 2013-09-27
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-05
• Last Update Posted: 2019-03-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 330

Inclusion Criteria

• a) age between 18 and 75 years,
• b) HCC with no previous treatment,
• c) the presence of major PVTT or less on imaging,
• d) Eastern Co-operative Group performance status 030 ,
• e) resectable disease

Exclusion Criteria

• a) Child-Pugh class B or C liver cirrhosis, or evidence of hepatic decompensation including ascites, esophageal or gastric variceal bleeding or hepatic encephalopathy, or ICGR-15 >15%,
• b) an American Society of Anesthesiologists (ASA) score ≥ 3,
• c) the presence of distant metastasis or other malignant diseases

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Preoperation TACE arm	Preoprative TACE	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
Preoperation TACE arm	Liver resection plus Thrombectomy	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
Resection arm	Liver resection plus Thrombectomy	Liver resection Plus Thrombectomy

Primary Outcome Measures

Name	Time	Method
overall survival time	5years

Secondary Outcome Measures

Name	Time	Method
Number of Adverse Events	30 days	All severe adverse events for the entire course of treatment, including treatment for primary tumor and recurrent tumor.
disease free survival	5 years

Trial Locations

Locations (1)

SunYat-sen University cancer center; 🇨🇳 Guangzhou, Guangdong, China