Transcatheter Arterial Chemoembolization Combined With Sorafenib for Unresectable Hepatocellular Carcinoma
1 other identifier
interventional
120
1 country
1
Brief Summary
Hepatocellular carcinoma (HCC) is the 6th most common cancer and the third most frequent cause of cancer death worldwide. Hepatic resection (HR) has been the standard treatment modality for HCC aiming at clinical cure. In both Europe and Unit States proposed guidelines for HCC, HR was recommend only for patients with a single HCC lesion and preserved liver function . Unfortunately, only 10%-30% of HCCs are amenable to such "curative" surgical resection at the time of diagnosis, because of tumor multifocality, portal vein invasion, and underlying advanced liver cirrhosis . Alternatively, transarterial chemoembolization (TACE) has become the most popular modality for palliative treatment for the other patients. However, the long term outcomes were generally poor for HCC patients treated with TACE. Recently, sorafenib has shown some promises in improvement of 3-month survival among patients with advanced HCC. It is claimed that sorafenib has become the standard of care for patients advanced HCC. Thus, the purpose of this study was to prospectively compare the effectiveness of sorafenib combined with TACE with that of TACE alone in the treatment of unresectable HCC .
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3 hepatocellular-carcinoma
Started Jan 2010
Longer than P75 for phase_3 hepatocellular-carcinoma
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2010
CompletedFirst Submitted
Initial submission to the registry
April 13, 2011
CompletedFirst Posted
Study publicly available on registry
April 16, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2018
CompletedFebruary 11, 2020
February 1, 2020
6.9 years
April 13, 2011
February 9, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Effectiveness of sorafenib combined with TACE
Measure:overall survival Measured from the date of TACE until the date of death or last visit
1 year
Secondary Outcomes (1)
Time to progression
1 year
Study Arms (2)
TACE group
ACTIVE COMPARATORTranscatheter arterial chemoembolization drugs and dosage:TACE with chemothrapy drugs (E-ADM 50mg, carboplatin 300 mg, MMC 8mg)and followed with embolization with lipiodol and absorbable gelatin sponge particles or polyvinyl alcohol particles.
TACE+sorafinib
EXPERIMENTALTACE+sorafinib
Interventions
Transcatheter arterial chemoembolization drugs and dosage:TACE with chemothrapy drugs (E-ADM 50mg, carboplatin 300 mg, MMC 8mg)and followed with embolization with lipiodol and absorbable gelatin sponge particles or polyvinyl alcohol particles. Oral sorafenib (400 mg BID) will be start the 2-4 weeks after the first TACE treatment and will continue until the patient shows disease progression, until unacceptable toxicity occurs, or until study termination.
Eligibility Criteria
You may qualify if:
- Adults patients ( 18-75 years of age) with a diagnosis of HCC which is not amenable to surgical resection or local ablative therapy
- Histological confirmed HCC or clinical/laboratory diagnosis of HCC or nodules larger than 2 cm with typical vascular features or AFP \> 200
- Patient must have quantifiable disease limited to the liver
- Patients must have at least one tumor lesion that meets both of the following criteria:
- The lesion can be accurately measured in at least one dimension according to RECIST criteria
- The lesion has not been previously treated with surgery, radiation therapy, radiofrequency ablation, percutaneous ethanol or acetic acid injection, or cryoablation.
- ECOG performance status (PS) \<2
- No prior targeted antiangiogenic therapy. Metronomic chemotherapies are allowed. At least 4 weeks since prior systemic chemotherapy,At least 4 weeks since prior TACE, At least 4 weeks since prior interferon.
- Not pregnant
- No significant baseline liver dysfunction. Cirrhotic status of Child-Pugh class A only
- No significant renal impairment (creatinine clearance \< 30 mL/minute) or patients on dialysis
- No current infections requiring antibiotic therapy
- Not on anticoagulation or suffering from a known bleeding disorder
- No unstable coronary artery disease or recent MI
You may not qualify if:
- Previous or concurrent cancer that is distinct in primary site or histology from HCC except cervical carcinoma in situ, treated basal-cell carcinoma of the skin, superficial bladder tumors (Ta, Tis \& T1), and any cancer curatively treated \> 3 years prior to entry is permitted
- Renal failure requiring hemo- or peritoneal dialysis
- Child-Pugh B \& C hepatic impairment
- History of cardiac disease: \> NY Heart Association (NYHA) class 2 congestive heart failure, active coronary artery disease, cardiac arrhythmias requiring anti-arrhythmic therapy other than beta blockers or digoxin, and uncontrolled hypertension. Myocardial infarction more than 6 months prior to study entry is permitted.
- Active clinically serious infections (\> CTCAEv3 grade 2)
- Known history of HIV
- Known central nervous system tumors including metastatic brain disease
- History of organ allograft
- Substance abuse (current), psychological, or social conditions that may interfere with the patient's participation in the study or evaluation of the study results.
- Known or suspected allergy to the investigational agents or any agent given in association with this trial.
- Patients unable to swallow oral medications.
- Pregnant or breast-feeding patients. Women of childbearing potential must have a negative pregnancy test performed within seven days prior to the start of the study drug. Both men and women enrolled in this trial must use adequate barrier birth control measures during the course of the trial.
- Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy
- Uncontrolled hypertension defined as systolic blood pressure \> 150 mmHg or diastolic blood pressure \> 90 mmHg, despite optimal medical management
- Thrombolic or embolic events such as a cerebrovascular accident including transient ischemic attacks within the past 6 months
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Cancer Centre of Sun Yat-Sen University
Guangzhou, 510060, China
Related Publications (1)
Parkin DM, Bray F, Ferlay J, Pisani P. Global cancer statistics, 2002. CA Cancer J Clin 2005;55:74-108. Llovet JM, Real MI, Montan˜a X, et al. Arterial embolisation or chemoembolisation versus symptomatic treatment in patients with unresectable hepatocellular carcinoma: a randomised controlled trial. Lancet. 2002;359:1734-59. Llovet JM, Ricci S, Mazzaferro V, Hilgard P, Gane E, Blanc JF, et al. Sorafenib in advanced hepatocellular carcinoma. N Engl J Med. 2008;359:378-90. Bruix J, Llovet JM. Major achievements in hepatocellular carcinoma. Lancet 2009 21;373:614-616.
BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
min-shan chen, M.D. Ph.D.
Department of Hepatobiliary Surgery, Cancer Centre of Sun Yat-Sen University
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- Only the radiologists who assessed the outcomes were blinded.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- professor
Study Record Dates
First Submitted
April 13, 2011
First Posted
April 16, 2013
Study Start
January 1, 2010
Primary Completion
December 1, 2016
Study Completion
December 1, 2018
Last Updated
February 11, 2020
Record last verified: 2020-02