Sorafenib VS TACE in HCC Patients With Portal Vein Invasion

Seoul National University

Status and phase: Terminated; Phase 2

Conditions: Hepatocellular Carcinoma

Treatments: Procedure: TACE for HCC with portal vein invasion; Drug: Sorafenib

Study type: Interventional

Funder types: Other

Identifiers

NCT01480817

STAP

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2 patients

Sex: All

Ages: 18 to 79 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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2 participants in 2 patient groups

Sorafenib

Active Comparator group

Description:

Sorafenib 400mg po bid

Treatment:

Drug: Sorafenib

TACE for HCC with portal vein invasion

Experimental group

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.

Treatment:

Procedure: TACE for HCC with portal vein invasion