Sorafenib VS TACE in HCC Patients With Portal Vein Invasion

Hepatocellular Carcinoma Clinical Trial

Official title:

An Open Label, Phase 2 Trial Comparing Sorafenib And TACE in Advanced Hepatocellular Carcinoma With Portal Vein Invasion

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01480817
• Other study ID #: STAP
• Status: Terminated
• Phase: Phase 2
• First received: November 20, 2011
• Last updated: April 28, 2016
• Start date: June 2012
• Est. completion date: December 2015

Study information

• Verified date: December 2013
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 79 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

Drug:
• Sorafenib
Sorafenib 400mg po bid

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.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to Progression (Efficacy)		every 6 weeks up to 3 years	No
Secondary	overall survival		every 6 weeks up to 3 years	No
Secondary	objective tumor response rate	Determined by dynamic-perfusion CT scan at the end of each cycle	every 6 weeks up to 3 years	No
Secondary	objective tumor control rate	Determined by dynamic-perfusion CT scan at the end of each cycle	every 6 weeks up to 3 years	No
Secondary	progression-free survival		every 6 weeks up to 3 years	No
Secondary	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	every 6 weeks up to 3 years	Yes
Secondary	Change of perfusion parameter		every 6 weeks up to 3 years	No
Secondary	Alpha feto protein (AFP) responsiveness	AFP responder : 20% reduction from baseline AFP level after 6 weeks of treatment	every 6 weeks up to 3 years	No