TACE and Sorafenib for Advanced Hepatocellular Carcinoma (HCC)

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

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00618384

Acronym

SOCRATES

Enrollment

Registered

2008-02-20

Start date

2008-01-31

Completion date

2011-08-31

Last updated

2012-06-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatocellular Carcinoma

Keywords

TACE, hepatocellular carcinoma

Brief summary

For patients with advanced HCC not suitable for resection or liver transplantation but without extrahepatic manifestations, local therapy with TACE is regarded as standard treatment. The present study is planned to evaluate the combination of TACE and sorafenib. A combination of TACE with a multitarget inhibitor like sorafenib may further improve the outcome of patients with HCC.

Interventions

DRUGSorafenib

patients get transarterial chemoembolization (TACE) will get film-coated tablets of Sorafenib (2 x 400 mg/day) until progressive disease

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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 medication * 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

Design outcomes

Primary

Measure	Time frame
determination of time to progression (TTP)	every 30 days after administration

Secondary

Measure	Time frame
adverse events	3-week-periods

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026