Hepatic Resection Versus Transcatheter Arterial Chemoembolization for Hepatocellular Carcinoma Complicated by Portal Vein Tumor Thrombosis

May 6, 2011 updated by: Sun Yat-sen University

Hepatic Resection Versus Transcatheter Arterial Chemoembolization for Hepatocellular Carcinoma Complicated by Portal Vein Tumor Thrombosis.A Prospective and Randomized Clinical Trial

The treatment for Hepatocellular Carcinoma (HCC) with Portal Vein Tumor Thrombosis (PVTT) is still controversial, and there is no universally agreed protocol for its treatment. Transarterial chemoembolization (TACE) has become the most popular palliative treatment for patients with unresectable HCC, and it is no longer considered as a contraindication to HCC with PVTT. Unfortunately, the long term outcomes are generally poor for HCC treated with TACE, especially for HCC with PVTT. HR remains the only therapeutic option that may still offer a chance of cure. With advances in surgical techniques, it has become feasible to remove all gross tumors, including PVTT which has extended to the main portal vein, safely by surgery. This study aimed to evaluate the safety and efficacy of HR as compared with TACE to treat patients with HCC with PVTT. The investigators also aimed to identify patient groups that might benefit more from either treatment with HR or TACE.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Hepatocellular carcinoma (HCC) is the sixth most common cancer and the third most frequent cause of cancer death worldwide. Hepatic resection (HR) is the conventional "curative" treatment for HCC. In both the European and the Unit States Proposed Guidelines for HCC, HR is recommended only for patients with preserved liver function and with a single HCC lesion. Unfortunately, because of tumor multifocality, portal vein invasion, and underlying advanced cirrhosis, only 10%-30% of HCCs are amenable to such a "curative" treatment at the time of diagnosis. Transarterial chemoembolization (TACE) has become the most popular palliative treatment for patients with unresectable HCC, and it is no longer considered as a contraindication to HCC with portal vein tumor thrombus (PVTT). Unfortunately, the long term outcomes are generally poor for HCC treated with TACE, especially for HCC with PVTT.

To improve on the results of treatment of HCC with PVTT, attempts have been made to perform HR for these patients . HCC with PVTT remains a contraindication to liver transplantation because of the high rate of tumor recurrence, and because of the severe shortage of donor organs. HR remains the only therapeutic option that may still offer a chance of cure. With advances in surgical techniques, it has become feasible to remove all gross tumors, including PVTT which has extended to the main portal vein, safely by surgery. More HCC with PVTT, which previously were considered as unresectable, have become resectable. Recent studies have even shown favorable long-term survival outcomes of HR in well-selected cases of HCC with PVTT. However, the survival outcomes of patients with HCC with PVTT treated with HR or with TACE have not been properly compared.

This study aimed to evaluate the safety and efficacy of HR as compared with TACE to treat patients with HCC with PVTT. The investigators also aimed to identify patient groups that might benefit more from either treatment with HR or TACE.

Study Type

Interventional

Enrollment (Anticipated)

180

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
        • Recruiting
        • Cancer Center Sun Yat-sen University
        • Contact:
        • Principal Investigator:
          • min-shan chen, M.D.,Ph.D.

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:

  1. age between 18 and 75 years,
  2. HCC with no previous treatment,
  3. the presence of PVTT on imaging,
  4. Eastern Co-operative Group performance status 0 ,
  5. resectable disease, which is defined as the possibility of completely removing all gross tumors and retaining a sufficient liver remnant to sustain life, as assessed by our surgery team.

Exclusion Criteria:

  1. the presence of extrahepatic spread on imaging,
  2. a Child-Pugh class C liver cirrhosis, or ICG-R15 >30%, or evidence of hepatic decompensation including ascites, esophageal or gastric variceal bleeding or hepatic encephalopathy,
  3. an American Society of Anesthesiologists (ASA) score ≥ 3

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: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: HR group
HR was carried out under general anesthesia using a right subcostal incision with a midline extension. Intraoperative ultrasound was routinely performed. Pringle's maneuver was routinely used with a clamp/unclamp time of 10 minutes/5 minutes.Thrombectomy was performed according to the location and extent of PVTT. The en bloc technique was used for patients if the portal vein branch could be ligated with a sufficient safety margin between its root and the tip of the thrombus
Procedure: hepatic resection
HR was carried out under general anesthesia using a right subcostal incision with a midline extension. Intraoperative ultrasound was routinely performed. Pringle's maneuver was routinely used with a clamp/unclamp time of 10 minutes/5 minutes.Thrombectomy was performed according to the location and extent of PVTT. The en bloc technique was used for patients if the portal vein branch could be ligated with a sufficient safety margin between its root and the tip of the thrombus
Experimental: TACE group
TACE with chemotherapy drugs (EADM 50mg, lobaplatin 50mg, and MMC 6mg )mixed with iodized oil lipidol
Procedure: TACE
TACE with chemotherapy drugs (EADM 50mg, lobaplatin 50mg, and MMC 6mg )mixed with iodized oil lipidol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
overall survival
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
Time to progression
Time Frame: 1 year
1 year

Collaborators and Investigators

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

Sponsor

Sun Yat-sen University

Investigators

  • Principal Investigator: min-shan chen, Ph.D.,M.D., Cancer Center, Sun Yat-set University

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

April 1, 2010

Primary Completion (Anticipated)

May 1, 2012

Study Completion (Anticipated)

May 1, 2013

Study Registration Dates

First Submitted

May 6, 2011

First Submitted That Met QC Criteria

May 6, 2011

First Posted (Estimate)

May 9, 2011

Study Record Updates

Last Update Posted (Estimate)

May 9, 2011

Last Update Submitted That Met QC Criteria

May 6, 2011

Last Verified

April 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HCC0011

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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