Status:
UNKNOWN
Efficacy and Safety of Concurrent TACE and Sorafenib in Patients With HCC and Extrahepatic Metastasis (COTSOM Study)
Lead Sponsor:
Asan Medical Center
Collaborating Sponsors:
Bayer
Conditions:
Hepatocellular Carcinoma
Metastasis
Eligibility:
All Genders
20+ years
Phase:
PHASE2
Brief Summary
This study is a phase II, prospective, open-label, single arm, single center study of the efficacy and safety of concurrent conventional transarterial chemoembolization (TACE) and sorafenib in patient...
Detailed Description
This is a single center, single arm, prospective, phase II study in patients with metastatic HCC. A total of 55 patients with HCC and newly diagnosed extrahepatic (lung, bone, lymph node, adrenal glan...
Eligibility Criteria
Inclusion
- Patients with HCC and newly diagnosed extrahepatic metastasis meeting of following criteria
- Clinical or histological diagnosis of HCC based on the guidelines: Early enhancement followed by late wash-out on dynamic liver imaging (CT or MRI) Or Pathological examination of liver biopsy
- Evidence of extrahepatic metastasis with any of following methods; CT, MRI, bone scan, positron emission tomography with FDG-PET, biopsy of metastatic lesion
- Preserved liver function classified as Child-Pugh A
- ECOG PS of 0-1
- Age of at least 20 years
- Patients is able to comply with scheduled visits, evaluation plan, and other study procedures
- Patient is willing to provide written informed consent
- There is no limitation of prior TACE session number in case that further TACE is still considered to be beneficial
- Women of childbearing potential must have a negative pregnancy test performed within 14 days of the start of treatment. All patients of child-bearing potential must use adequate birth control measures during the course of the trial (barrier method of birth control) and up to at least 30 days of last dose.
Exclusion
- Presence of any of following criteria
- Patients who are diagnosed as not eligible for further TACE before screening
- Patients with advanced liver disease as defined below:
- Child Pugh B and C
- Encephalopathy
- Ascites
- Complete occlusion of main portal vein (PV) by HCC
- Patients with brain metastasis
- Inadequate liver function that could not perform TACE:
- AST \> 5 X ULN(upper limit normal) or ALT \> 5 X ULN
- Total bilirubin \> 2.0 mg/dL
- Prothrombin time INR \> 1.7
- Inadequate bone marrow function (absolute neutrophil count \< 1,500/μL, Hemoglobin (Hgb) \< 8 g/dL, platelet count \< 50,000/μL)
- Inadequate renal function (creatinine \> 1.5 x ULN)
- Treatment with previous local therapy such as resection of HCC, radiofrequency ablation (RFA), percutaneous ethanol injection (PEI) \< 4 weeks prior to the screening
- Prior sorafenib use
- Investigational drugs or other molecular target drugs ongoing or completed \< 4 weeks prior to the screening
- Clinically significant gastrointestinal bleeding within 4 weeks prior to start of study drug
- Uncontrolled bleeding varices.
- History of cardiac disease:
- Congestive heart failure \>NYHA class 2
- Active coronary artery disease (CAD) (myocardial infarction more than 6 months prior to study entry is allowed)
- Unstable angina (anginal symptoms at rest), new-onset angina within 3 months before screening
- Cardiac arrhythmias which are poorly controlled with anti-arrhythmic therapy or requiring pace maker
- Uncontrolled hypertension
- Active clinically serious infections except for HBV and HCV infection
- Patients with HIV
- Subjects with thrombotic, embolic, venous, or arterial events, such as cerebrovascular accident (including transient ischemic attacks) within 6 months before screening
- Recently treated or concurrent cancer that has a primary site or histology distinct from HCC except any cancer curatively treated more than 3 years prior to screening
- Pregnant or breast-feeding subjects
- Major surgery, open biopsy, or significant traumatic injury 4 weeks before screening
- Presence of a non-healing wound, non-healing ulcer, or bone fracture
- Subjects who have used strong CYP3A4 inducers within 4 weeks before screening
- Known or suspected allergy or hypersensitivity to any of the study drugs, study drug classes, or excipients of the formulations given during the course of this trial
- Any other condition which, in the opinion of the investigator, would make the patient unsuitable for enrollment or could interfere with the completing the study
Key Trial Info
Start Date :
December 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2018
Estimated Enrollment :
55 Patients enrolled
Trial Details
Trial ID
NCT02311205
Start Date
December 1 2014
End Date
June 1 2018
Last Update
December 18 2017
Active Locations (1)
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1
Asan Medical Center
Seoul, South Korea