Clinical trial NCT01952353: Preoperative Transarterial Chemoembolization for Resectable HCC With Portal Venous Invasion
Official title: Efficacy of Preoperative Transarterial Chemoembolization for Resectable Hepatocellular Carcinoma With Portal Vein Tumor Thrombosis: A Prospective Non-Randomized Comparative Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Resectable Hepatocellular Carcinoma With Portal Vein Tumor Thrombus
Keywords: Hepatocellular Carcinoma; Transarterial Chemoembolization; Hepatic Resection; Portal Vein Tumor Thrombosis
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2013-09-27
Enrollment: 330
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: overall survival time
timeFrame: 5years
Secondary outcomes:
measure: disease free survival
timeFrame: 5 years
measure: Number of Adverse Events
timeFrame: 30 days
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: SunYat-sen University cancer center
state: Guangdong
Study officials:
affiliation: Sun Yat-sen University
name: Ming Shi, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Peng ZW, Guo RP, Zhang YJ, Lin XJ, Chen MS, Lau WY. Hepatic resection versus transcatheter arterial chemoembolization for the treatment of hepatocellular carcinoma with portal vein tumor thrombus. Cancer. 2012 Oct 1;118(19):4725-36. doi: 10.1002/cncr.26561. Epub 2012 Feb 22.