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Sorafenib VS TACE in HCC Patients With Portal Vein Invasion

Primary Purpose

Hepatocellular Carcinoma

Status
Terminated
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Sorafenib
TACE for HCC with portal vein invasion
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatocellular Carcinoma

Eligibility Criteria

18 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. 80 > Age >= 18 years.
  2. Child-Pugh class A (class B could be included when Childs score is 7).

  3. Hepatocellular carcinoma with major branch of portal vein invasion on dynamic CT or MRI

    • not only newly diagnosed treatment-naive patients,
    • but also HCC patients previously treated with other therapies in case of development of major branch of portal vein invasion

  4. Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements:

    • White blood cell counts (WBC) >= 2,000 /μl, Absolute neutrophil count (ANC) > 1,200/μl
    • Hemoglobin >= 8.0 g/dl
    • Platelet count > 50,000/μl
    • Serum creatinine < 1.7 mg/dl
    • Total bilirubin =< 3.0 mg/dl
    • Prothrombin Time (PT)-international normalized ratio (INR) =< 2.3 or Prothrombin Time (PT)-sec =< 6 sec
  5. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2.

Exclusion Criteria:

  1. Child-Pugh score >= 8.
  2. Age < 18 or >= 80 years.
  3. ECOG Performance Status >= 3.
  4. Recipient of living donor or deceased donor liver transplantation
  5. Patients unable to understand the contents of informed consent or refuse to sign the informed consent.
  6. Patients with evidence of uncontrolled or severe medical conditions requiring treatment.

Sites / Locations

  • Seoul National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Sorafenib

TACE for HCC with portal vein invasion

Arm Description

Sorafenib 400mg po bid

Antineoplastic agents are directly injected into the hepatic artery, allowing high intratumoral concentrations of drugs and thereby reducing systemic side effects. The mixture of chemotherapeutic agents and iodized oil is almost completely retained in neoplastic nodules and can remain in HCC tissue for a long time. Subsequent mechanical embolization of the artery feeding the neoplasm causes ischemic damage to the tumor and prolongs the duration of the effects of chemotherapeutic agents.

Outcomes

Primary Outcome Measures

Time to Progression (Efficacy)

Secondary Outcome Measures

overall survival
objective tumor response rate
Determined by dynamic-perfusion CT scan at the end of each cycle
objective tumor control rate
Determined by dynamic-perfusion CT scan at the end of each cycle
progression-free survival
the adverse event rate and examine the toxicities
The investigators will evaluate the adverse event according to Common Toxicity Criteria(version 4.0)by National Cancer Institute of National Institutes of Health
Change of perfusion parameter
Alpha feto protein (AFP) responsiveness
AFP responder : 20% reduction from baseline AFP level after 6 weeks of treatment

Full Information

First Posted
November 20, 2011
Last Updated
April 28, 2016
Sponsor
Seoul National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01480817
Brief Title
Sorafenib VS TACE in HCC Patients With Portal Vein Invasion
Official Title
An Open Label, Phase 2 Trial Comparing Sorafenib And TACE in Advanced Hepatocellular Carcinoma With Portal Vein Invasion
Study Type
Interventional

2. Study Status

Record Verification Date
December 2013
Overall Recruitment Status
Terminated
Why Stopped
Difficulty of participant enrollment.
Study Start Date
June 2012 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Seoul National University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The investigators are going to compare the therapeutic effect of sorafenib and transarterial chemoembolization in advanced hepatocellular carcinoma with major branch of portal vein invasion.
Detailed Description
TACE is an established therapy for patients with unresectable hepatocellular carcinoma (HCC) and has been shown to significantly improve survival in these patients compared to no treatment. Moreover, TACE can be performed safely and may improve the overall survival of patients with HCC and major branch of portal vein invasion. Sorafenib, already approved for HCC, could lead to significantly improvement in tumor control and survival in patients with advanced stage HCC. So far there are no head to head comparison reports about the efficacy of Sorafenib and TACE. Here the investigators evaluate the efficacy of sorafenib and TACE in advanced HCC with major branch of portal vein invasion.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sorafenib
Arm Type
Active Comparator
Arm Description
Sorafenib 400mg po bid
Arm Title
TACE for HCC with portal vein invasion
Arm Type
Experimental
Arm Description
Antineoplastic agents are directly injected into the hepatic artery, allowing high intratumoral concentrations of drugs and thereby reducing systemic side effects. The mixture of chemotherapeutic agents and iodized oil is almost completely retained in neoplastic nodules and can remain in HCC tissue for a long time. Subsequent mechanical embolization of the artery feeding the neoplasm causes ischemic damage to the tumor and prolongs the duration of the effects of chemotherapeutic agents.
Intervention Type
Drug
Intervention Name(s)
Sorafenib
Other Intervention Name(s)
Nexavar
Intervention Description
Sorafenib 400mg po bid
Intervention Type
Procedure
Intervention Name(s)
TACE for HCC with portal vein invasion
Other Intervention Name(s)
TACE
Intervention Description
The volume of iodized oil ranged from 2 to 12 mL, and the amount of doxorubicin ranged from 10 to 60 mg. Gelatin sponge particles were mixed with mitomycin and contrast material.Cisplatin was infused at the tumor feeder vessels as a solution with a concentration of 0.5 mg/mL at a rate of 5-10 mL/min. The total amount of cisplatin used ranged from 50 to 100 mg depending on the patient's body weight and the level of infusion.
Primary Outcome Measure Information:
Title
Time to Progression (Efficacy)
Time Frame
every 6 weeks up to 3 years
Secondary Outcome Measure Information:
Title
overall survival
Time Frame
every 6 weeks up to 3 years
Title
objective tumor response rate
Description
Determined by dynamic-perfusion CT scan at the end of each cycle
Time Frame
every 6 weeks up to 3 years
Title
objective tumor control rate
Description
Determined by dynamic-perfusion CT scan at the end of each cycle
Time Frame
every 6 weeks up to 3 years
Title
progression-free survival
Time Frame
every 6 weeks up to 3 years
Title
the adverse event rate and examine the toxicities
Description
The investigators will evaluate the adverse event according to Common Toxicity Criteria(version 4.0)by National Cancer Institute of National Institutes of Health
Time Frame
every 6 weeks up to 3 years
Title
Change of perfusion parameter
Time Frame
every 6 weeks up to 3 years
Title
Alpha feto protein (AFP) responsiveness
Description
AFP responder : 20% reduction from baseline AFP level after 6 weeks of treatment
Time Frame
every 6 weeks up to 3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 80 > Age >= 18 years. Child-Pugh class A (class B could be included when Childs score is 7). Hepatocellular carcinoma with major branch of portal vein invasion on dynamic CT or MRI not only newly diagnosed treatment-naive patients, but also HCC patients previously treated with other therapies in case of development of major branch of portal vein invasion Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements: White blood cell counts (WBC) >= 2,000 /μl, Absolute neutrophil count (ANC) > 1,200/μl Hemoglobin >= 8.0 g/dl Platelet count > 50,000/μl Serum creatinine < 1.7 mg/dl Total bilirubin =< 3.0 mg/dl Prothrombin Time (PT)-international normalized ratio (INR) =< 2.3 or Prothrombin Time (PT)-sec =< 6 sec Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2. Exclusion Criteria: Child-Pugh score >= 8. Age < 18 or >= 80 years. ECOG Performance Status >= 3. Recipient of living donor or deceased donor liver transplantation Patients unable to understand the contents of informed consent or refuse to sign the informed consent. Patients with evidence of uncontrolled or severe medical conditions requiring treatment.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jung-Hwan Yoon, M.D., Ph.D.
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of

12. IPD Sharing Statement

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Sorafenib VS TACE in HCC Patients With Portal Vein Invasion

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