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

This study has been completed.
Sponsor:
Collaborators:
Guangzhou 8th People's Hospital
Kaiping Central Hospital
The 458 Hospital of Chinese People's Liberation Army
Information provided by (Responsible Party):
Shi Ming, Sun Yat-sen University
ClinicalTrials.gov Identifier:
NCT01600196
First received: May 13, 2012
Last updated: May 15, 2012
Last verified: May 2012
  Purpose

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.


Condition Intervention Phase
Hepatocellular Carcinoma With Portal Vein Tumor Thrombus
Procedure: Liver resection plus Thrombectomy
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Surgical Resection Versus Best Supportive Care for Resectable Hepatocellular Carcinoma Invading the First Branch of Portal Vein

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Survival time [ Time Frame: 5-years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of Adverse Events [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    Number of adverse events, and number of patients who developed adverse event. Postoperative adverse events were graded based on the Clavien-Dindo classification.


Enrollment: 126
Study Start Date: January 2006
Study Completion Date: July 2011
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Resection arm
Liver resection Plus Thrombectomy
Procedure: Liver resection plus Thrombectomy
Liver resection plus Thrombectomy
Other Name: Removal of all tumor tissue by surgery
No Intervention: Best support care arm
Best supportive care

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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  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: NCT01600196

Locations
China, Guangdong
Cancer Center, Sun Yat-sen University
Guangzhou, Guangdong, China, 510060
Sponsors and Collaborators
Sun Yat-sen University
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
  More Information

Additional Information:
Publications:
Responsible Party: Shi Ming, Professor, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT01600196     History of Changes
Other Study ID Numbers: HCC2005009
Study First Received: May 13, 2012
Last Updated: May 15, 2012
Health Authority: China: Ministry of Health

Keywords provided by Sun Yat-sen University:
Hepatectomy
Thrombectomy
Hepatocellular carcinoma
Portal vein tumor thrombus

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

ClinicalTrials.gov processed this record on November 20, 2014