Sorafenib VS TACE in HCC Patients With Portal Vein Invasion

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by Seoul National University Hospital
Sponsor:
Information provided by (Responsible Party):
Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01480817
First received: November 20, 2011
Last updated: December 2, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention Phase
Hepatocellular Carcinoma
Drug: Sorafenib
Procedure: TACE for HCC with portal vein invasion
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open Label, Phase 2 Trial Comparing Sorafenib And TACE in Advanced Hepatocellular Carcinoma With Portal Vein Invasion

Resource links provided by NLM:


Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • Time to Progression (Efficacy) [ Time Frame: every 6 weeks up to 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • overall survival [ Time Frame: every 6 weeks up to 3 years ] [ Designated as safety issue: No ]
  • objective tumor response rate [ Time Frame: every 6 weeks up to 3 years ] [ Designated as safety issue: No ]
    Determined by dynamic-perfusion CT scan at the end of each cycle

  • objective tumor control rate [ Time Frame: every 6 weeks up to 3 years ] [ Designated as safety issue: No ]
    Determined by dynamic-perfusion CT scan at the end of each cycle

  • progression-free survival [ Time Frame: every 6 weeks up to 3 years ] [ Designated as safety issue: No ]
  • the adverse event rate and examine the toxicities [ Time Frame: every 6 weeks up to 3 years ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: every 6 weeks up to 3 years ] [ Designated as safety issue: No ]
  • Alpha feto protein (AFP) responsiveness [ Time Frame: every 6 weeks up to 3 years ] [ Designated as safety issue: No ]
    AFP responder : 20% reduction from baseline AFP level after 6 weeks of treatment


Estimated Enrollment: 40
Study Start Date: June 2012
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Sorafenib
Sorafenib 400mg po bid
Drug: Sorafenib
Sorafenib 400mg po bid
Other Name: Nexavar
Experimental: TACE for HCC with portal vein invasion
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.
Procedure: TACE for HCC with portal vein invasion
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.
Other Name: TACE

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.

  Eligibility

Ages Eligible for Study:   18 Years to 79 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  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: NCT01480817

Contacts
Contact: Jung-Hwan Yoon, M.D., Ph. D. 82-2-2072-2228 yoonjh@snu.ac.kr

Locations
Korea, Republic of
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of, 110-744
Contact: Jung-Hwan Yoon, M.D., Ph. D.    82-2-2072-2228      
Principal Investigator: Jung-Hwan Yoon, M.D., Ph. D.         
Sponsors and Collaborators
Seoul National University Hospital
Investigators
Principal Investigator: Jung-Hwan Yoon, M.D., Ph.D. Seoul National University Hospital
  More Information

No publications provided

Responsible Party: Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01480817     History of Changes
Other Study ID Numbers: STAP
Study First Received: November 20, 2011
Last Updated: December 2, 2013
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Sorafenib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 29, 2014