Clinical trial NCT01600196: Resection vs. Best Supportive Care for Hepatocellular Carcinoma (HCC) With Portal Venous Thrombus
Official title: Surgical Resection Versus Best Supportive Care for Resectable Hepatocellular Carcinoma Invading the First Branch of Portal Vein
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Hepatocellular Carcinoma With Portal Vein Tumor Thrombus
Keywords: Hepatectomy
Thrombectomy
Hepatocellular carcinoma
Portal vein tumor thrombus
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
Collaborators: name: Guangzhou 8th People's Hospital
name: Kaiping Central Hospital
name: The 458 Hospital of Chinese People's Liberation Army
First posted: 2012-05-16
Enrollment: 126
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the long-term efficacy and safety of surgical resection compared with best supportive care in patients with resectable hepatocellular carcinoma (HCC) with portal venous thrombus (PVTT) in the first branch of portal vein.

Detailed description: Advances in surgical techniques have made it possible to remove all macroscopic tumors in more hepatocellular carcinoma (HCC) patients with portal venous thrombus (PVTT). However, the benefit of such surgery remains largely controversial. On one hand, many clinicians believe that surgical resection offers the only chance for long term survival. Many studies reported a median survival of 6-40 months after liver resection and thrombectomy, and some cases achieved long term survival.On the other hand, the strength of evidences arising from these studies was widely questioned because of their retrospective nature and study design. Most of them were single arm cohort study. A few studies used control groups consisted of patients with unresectable HCC and PVTT underwent transarterial chemoembolization. This led to obvious selection bias. Because patients with unresectable HCC and PVTT have a much poorer prognosis compared with resectable disease because of more widespread tumor focus and less residual liver, even if their baseline characters are comparable.

Eligibility criteria: Inclusion Criteria:

* The diagnosis of HCC was made according to AASLD guidelines
* Main tumor ≥ 7 cm
* Imaging confirmed the presence of PVTT in the first branches but not
* Extend into the main trunk of portal vein
* Eastern Co-operative Group performance
* Resectable disease

Exclusion Criteria:

* Child-Pugh class B or C liver cirrhosis
* An American Society of Anesthesiologists (ASA) score ≥ 3
* Extrahepatic metastasis
* Patients had access to sorafenib.

Primary outcomes:
measure: Survival time
timeFrame: 5-years
Secondary outcomes:
measure: Number of Adverse Events
timeFrame: 30 days
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Cancer Center, Sun Yat-sen University
state: Guangdong
Study officials:
affiliation: Sun Yat-sen University
name: Ming Shi, MD.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Le Treut YP, Hardwigsen J, Ananian P, Saisse J, Gregoire E, Richa H, Campan P. Resection of hepatocellular carcinoma with tumor thrombus in the major vasculature. A European case-control series. J Gastrointest Surg. 2006 Jun;10(6):855-62. doi: 10.1016/j.gassur.2005.12.011.