Resection vs. Best Supportive Care for Hepatocellular Carcinoma (HCC) With Portal Venous Thrombus

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

126 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-01-31

Study Completion Date

2011-07-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Hepatocellular Carcinoma With Portal Vein Tumor Thrombus

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Resection arm

Liver resection Plus Thrombectomy

Group Type EXPERIMENTAL

Liver resection plus Thrombectomy

Intervention Type PROCEDURE

Liver resection plus Thrombectomy

Best support care arm

Best supportive care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Liver resection plus Thrombectomy

Intervention Type PROCEDURE

Other Intervention Names

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Removal of all tumor tissue by surgery

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No