Sorafenib VS TACE in HCC Patients With Portal Vein Invasion

Phase 2

Terminated

• Conditions: Hepatocellular Carcinoma
• Interventions: Drug: Sorafenib; Procedure: TACE for HCC with portal vein invasion

• Registration Number: NCT01480817
• Lead Sponsor: Seoul National University Hospital

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.

Study Timeline

• Study First Submitted: 2011-11-20
• Study First Submitted QC: 2011-11-24
• Study First Posted: 2011-11-29
• Study Start: 2012-06
• Status Verified: 2013-12
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Last Update Submitted: 2016-04-28
• Last Update Posted: 2016-04-29

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 2

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sorafenib	Sorafenib	Sorafenib 400mg po bid
TACE for HCC with portal vein invasion	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.

Primary Outcome Measures

Name	Time	Method
Time to Progression (Efficacy)	every 6 weeks up to 3 years

Secondary Outcome Measures

Name	Time	Method
objective tumor control rate	every 6 weeks up to 3 years	Determined by dynamic-perfusion CT scan at the end of each cycle
progression-free survival	every 6 weeks up to 3 years
overall survival	every 6 weeks up to 3 years
objective tumor response rate	every 6 weeks up to 3 years	Determined by dynamic-perfusion CT scan at the end of each cycle
the adverse event rate and examine the toxicities	every 6 weeks up to 3 years	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	every 6 weeks up to 3 years
Alpha feto protein (AFP) responsiveness	every 6 weeks up to 3 years	AFP responder : 20% reduction from baseline AFP level after 6 weeks of treatment

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of