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Phase II Study Evaluating Transarterial Chemoembolization (TACE) in Combination With Sorafenib for the Treatment of Advanced Hepatocellular Carcinoma (HCC)

Phase 2
18 Years
Not Enrolling
Hepatocellular Carcinoma

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Trial Information

Phase II Study Evaluating Transarterial Chemoembolization (TACE) in Combination With Sorafenib for the Treatment of Advanced Hepatocellular Carcinoma (HCC)

Inclusion Criteria:

- with histologically confirmed HCC not suitable for resection or liver transplantation

- Patients with measurable disease according to RECIST

- Performance status ECOG 0-2

- Normal organ and bone marrow function (defined)

- Women of childbearing potential must have performed a negative serum pregnancy test

- male or female patients must use an approved contraceptive method during treatment
and for 3 months after end of treatment after the end of treatment with study

- Written informed consent

Exclusion Criteria:

- Patient is eligible for liver resection or liver transplantation

- Extrahepatic tumor manifestation

- Thrombosis of the portal vein

- > 8 points according to Child Pugh classification

- Prior TACE or RFTA or any other local ablative treatment

- Prior systemic anticancer chemotherapy or radiotherapy for HCC

- Total bilirubin > 4.5 mg/dl

- Life expectancy of less than 12 weeks

- Esophageal varices grade III without prophylactic band ligation

- Cardiac diseases (defined)

- Uncontrolled hypertension

- Known or suspected hyperthyroid state

- Known brain metastasis

- Patients with seizure disorder requiring medication

- History of organ allograft

- Active clinically serious infections > CTCAE grade 2

- Thrombotic or embolic events

- Hemorrhage/bleeding event (defined)

- Acute variceal bleeding

- Therapeutic anticoagulation with vitamin K antagonists (defined)

- Known or suspected allergies to sorafenib, doxorubicin or lipiodol or any agent given
in the course of this trial

- Contraindications to the use of sorafenib, doxorubicin or lipiodol

- Previous cancer distinct in primary site or histology from HCC (defined)

- substance abuse

- Participation in another clinical trial with any investigational study drug

- Lactating women

- Incapability to give valid informed consent

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

determination of time to progression (TTP)

Outcome Time Frame:

every 30 days after administration

Safety Issue:


Principal Investigator

A. Erhardt, PD Dr.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Department of Gastroenterology, Hepatology and Infectiology University Duesseldorf


Germany: Federal Institute for Drugs and Medical Devices

Study ID:




Start Date:

January 2008

Completion Date:

August 2011

Related Keywords:

  • Hepatocellular Carcinoma
  • TACE
  • hepatocellular carcinoma
  • Carcinoma
  • Carcinoma, Hepatocellular