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

January 22, 2019 updated by: Shi Ming, Sun Yat-sen University

Surgical Resection Versus Best Supportive Care for Resectable Hepatocellular Carcinoma Invading the First Branch of Portal Vein

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

126

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510060
        • Cancer Center, Sun Yat-sen University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Resection arm
Liver resection Plus Thrombectomy
Procedure: Liver resection plus Thrombectomy
Liver resection plus Thrombectomy
Other Names:
  • Removal of all tumor tissue by surgery
NO_INTERVENTION: Best support care arm
Best supportive care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Survival time
Time Frame: 5-years
5-years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Adverse Events
Time Frame: 30 days
Number of adverse events, and number of patients who developed adverse event. Postoperative adverse events were graded based on the Clavien-Dindo classification.
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sun Yat-sen University

Collaborators

Guangzhou 8th People's Hospital
Kaiping Central Hospital
The 458 Hospital of Chinese People's Liberation Army

Investigators

  • Principal Investigator: Ming Shi, MD., Sun Yat-sen University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2006

Primary Completion (ACTUAL)

July 1, 2009

Study Completion (ACTUAL)

July 1, 2011

Study Registration Dates

First Submitted

May 13, 2012

First Submitted That Met QC Criteria

May 15, 2012

First Posted (ESTIMATE)

May 16, 2012

Study Record Updates

Last Update Posted (ACTUAL)

January 23, 2019

Last Update Submitted That Met QC Criteria

January 22, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HCC2005009

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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