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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2010 by Sun Yat-sen University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Sun Yat-sen University
ClinicalTrials.gov Identifier:
NCT01350206
First received: May 6, 2011
Last updated: NA
Last verified: April 2010
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Hepatocellular Carcinoma With PVTT
Procedure: hepatic resection
Procedure: TACE
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Hepatic Resection Versus Transcatheter Arterial Chemoembolization for Hepatocellular Carcinoma Complicated by Portal Vein Tumor Thrombosis.A Prospective and Randomized Clinical Trial

Resource links provided by NLM:


Further study details as provided by Sun Yat-sen University:

Primary Outcome Measures:
  • overall survival [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to progression [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 180
Study Start Date: April 2010
Estimated Study Completion Date: May 2013
Estimated Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01350206

Contacts
Contact: Min-Shan Chen, M.D. Ph.D. (8620) 8734 3117 Chminsh@mail.sysu.edu.cn

Locations
China, Guangdong
Cancer Center Sun Yat-sen University Recruiting
Guangzhou, Guangdong, China, 510060
Contact: Min-Shan Chen, M.D. Ph.D.    (8620) 8734 3117    Chminsh@mail.sysu.edu.cn   
Principal Investigator: min-shan chen, M.D.,Ph.D.         
Sponsors and Collaborators
Sun Yat-sen University
Investigators
Principal Investigator: min-shan chen, Ph.D.,M.D. Cancer Center, Sun Yat-set University
  More Information

No publications provided

Responsible Party: Cancer Center, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT01350206     History of Changes
Other Study ID Numbers: HCC0011
Study First Received: May 6, 2011
Last Updated: May 6, 2011
Health Authority: China: Ministry of Health

Keywords provided by Sun Yat-sen University:
Carcinoma,Hepatocellular
Liver Neoplasms
Therapeutic
Chemoembolization,
TACE
hepatic resection

Additional relevant MeSH terms:
Carcinoma
Thrombosis
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases

ClinicalTrials.gov processed this record on August 18, 2014