Hepatocellular Carcinoma Clinical Trial
Official title:
Transcatheter Arterial Chemoembolization Combined With Sorafenib for Unresectable Hepatocellular Carcinoma
Verified date | February 2020 |
Source | Sun Yat-sen University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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 .
Status | Completed |
Enrollment | 120 |
Est. completion date | December 2018 |
Est. primary completion date | December 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility |
Inclusion Criteria: 1. Adults patients ( 18-75 years of age) with a diagnosis of HCC which is not amenable to surgical resection or local ablative therapy 2. Histological confirmed HCC or clinical/laboratory diagnosis of HCC or nodules larger than 2 cm with typical vascular features or AFP > 200 3. Patient must have quantifiable disease limited to the liver 4. Patients must have at least one tumor lesion that meets both of the following criteria: 5. The lesion can be accurately measured in at least one dimension according to RECIST criteria 6. The lesion has not been previously treated with surgery, radiation therapy, radiofrequency ablation, percutaneous ethanol or acetic acid injection, or cryoablation. 7. ECOG performance status (PS) <2 8. 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. 9. Not pregnant 10. No significant baseline liver dysfunction. Cirrhotic status of Child-Pugh class A only 11. No significant renal impairment (creatinine clearance < 30 mL/minute) or patients on dialysis 12. No current infections requiring antibiotic therapy 13. Not on anticoagulation or suffering from a known bleeding disorder 14. No unstable coronary artery disease or recent MI Exclusion Criteria: 1. 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 2. Renal failure requiring hemo- or peritoneal dialysis 3. Child-Pugh B & C hepatic impairment 4. 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. 5. Active clinically serious infections (> CTCAEv3 grade 2) 6. Known history of HIV 7. Known central nervous system tumors including metastatic brain disease 8. History of organ allograft 9. Substance abuse (current), psychological, or social conditions that may interfere with the patient's participation in the study or evaluation of the study results. 10. Known or suspected allergy to the investigational agents or any agent given in association with this trial. 11. Patients unable to swallow oral medications. 12. 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. 13. Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy 14. Uncontrolled hypertension defined as systolic blood pressure > 150 mmHg or diastolic blood pressure > 90 mmHg, despite optimal medical management 15. Thrombolic or embolic events such as a cerebrovascular accident including transient ischemic attacks within the past 6 months 16. Pulmonary hemorrhage/bleeding event > CTCAE Grade 2 within 4 weeks of first dose of study drug 17. Any other hemorrhage/bleeding event > CTCAE Grade 3 within 4 weeks of first dose of study drug 18. Serious non-healing wound, ulcer, or bone fracture |
Country | Name | City | State |
---|---|---|---|
China | Cancer Centre of Sun Yat-Sen University | Guangzhou |
Lead Sponsor | Collaborator |
---|---|
Sun Yat-sen University |
China,
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.
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Time to progression | 1 year |
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