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

Primary Purpose

Hepatocellular Carcinoma With PVTT

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
hepatic resection
TACE
Sponsored by
Sun Yat-sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatocellular Carcinoma With PVTT focused on measuring Carcinoma,Hepatocellular, Liver Neoplasms, Therapeutic, Chemoembolization,, TACE, hepatic resection

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Cancer Center Sun Yat-sen UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

HR group

TACE group

Arm Description

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

TACE with chemotherapy drugs (EADM 50mg, lobaplatin 50mg, and MMC 6mg )mixed with iodized oil lipidol

Outcomes

Primary Outcome Measures

overall survival

Secondary Outcome Measures

Time to progression

Full Information

First Posted
May 6, 2011
Last Updated
May 6, 2011
Sponsor
Sun Yat-sen University
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1. Study Identification

Unique Protocol Identification Number
NCT01350206
Brief Title
Hepatic Resection Versus Transcatheter Arterial Chemoembolization for Hepatocellular Carcinoma Complicated by Portal Vein Tumor Thrombosis
Official Title
Hepatic Resection Versus Transcatheter Arterial Chemoembolization for Hepatocellular Carcinoma Complicated by Portal Vein Tumor Thrombosis.A Prospective and Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2010
Overall Recruitment Status
Unknown status
Study Start Date
April 2010 (undefined)
Primary Completion Date
May 2012 (Anticipated)
Study Completion Date
May 2013 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Sun Yat-sen University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma With PVTT
Keywords
Carcinoma,Hepatocellular, Liver Neoplasms, Therapeutic, Chemoembolization,, TACE, hepatic resection

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
180 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
HR group
Arm Type
Experimental
Arm Description
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
Arm Title
TACE group
Arm Type
Experimental
Arm Description
TACE with chemotherapy drugs (EADM 50mg, lobaplatin 50mg, and MMC 6mg )mixed with iodized oil lipidol
Intervention Type
Procedure
Intervention Name(s)
hepatic resection
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
TACE
Intervention Description
TACE with chemotherapy drugs (EADM 50mg, lobaplatin 50mg, and MMC 6mg )mixed with iodized oil lipidol
Primary Outcome Measure Information:
Title
overall survival
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Time to progression
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: age between 18 and 75 years, HCC with no previous treatment, the presence of PVTT on imaging, Eastern Co-operative Group performance status 0 , 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: the presence of extrahepatic spread on imaging, 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, an American Society of Anesthesiologists (ASA) score ≥ 3
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Min-Shan Chen, M.D. Ph.D.
Phone
(8620) 8734 3117
Email
Chminsh@mail.sysu.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
min-shan chen, Ph.D.,M.D.
Organizational Affiliation
Cancer Center, Sun Yat-set University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cancer Center Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Min-Shan Chen, M.D. Ph.D.
Phone
(8620) 8734 3117
Email
Chminsh@mail.sysu.edu.cn
First Name & Middle Initial & Last Name & Degree
min-shan chen, M.D.,Ph.D.

12. IPD Sharing Statement

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

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