Randomized Trial Comparing Sorafenib and Transarterial Chemoembolization Plus External Beam Radiotherapy in Patients With Hepatocellular Carcinoma Showing Macroscopic Vascular Invasion
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Asan Medical Center
- Enrollment
- 90
- Locations
- 1
- Primary Endpoint
- Progression-free survival (PFS) rate
Study Overview
Brief Summary
To evaluate and compare the efficacy and safety of sorafenib versus trans-arterial chemoembolization plus external beam radiation therapy in patients with hepatocellular carcinoma invading major intrahepatic vessels
Detailed Description
Current practice guidelines recommend only sorafenib for patients with hepatocellular carcinoma invading major intrahepatic vessels. However, recent data from observational studies suggest that the combination of transarterial chemoembolization and external beam radiotherapy would be as effective as sorafenib.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age >19 years
- •Child-Pugh class A liver function
- •Performance status: Eastern Cooperative Oncology Group (ECOG) score 0 or 1
- •Hepatocellular carcinoma (HCC) confirmed by dynamic CT or MRI, or by biopsy
- •HCC invasion of first or second branch portal vein or hepatic vein or inferior vena cava
- •Reserved unilateral portal blood flow at least in partial
- •HCC size larger than 1 cm and less than 50% of total liver volume
- •No confirmed extrahepatic metastasis
- •Adequate hematopoietic function Hemoglobin ≥ 8.5 g/dL Absolute neutrophil count ≥ 750/mm3 Platelet count ≥ 30,000/mm3
- •Creatinine < 1.5mg/dL
- •No plan for pregnancy or breast feeding. Active contraception.
- •Willing to give informed consent
Exclusion Criteria
- •Prior history to or exposure of transarterial chemoembolization, external beam radiation to liver, or sorafenib
- •Complete obstruction of hepatic outflow
- •Confirmed extrahepatic metastasis of HCC
- •HCC occupying more than 50% of liver volume
- •Uncontrolled ascites of hepatic encephalopathy
- •Prior liver transplantation
- •Positive for human immunodeficiency virus (HIV)
- •Active gastric or duodenal ulcer
- •Other uncontrolled comorbidities or malignancy
- •Inability to give informed consent
Arms & Interventions
TACE+External beam RT
Transarterial chemoembolization plus external beam radiation therapy
Intervention: TACE+External beam RT (Radiation)
Sorafenib
Sorafenib 800 mg/day orally
Intervention: Sorafenib (Drug)
Outcomes
Primary Outcomes
Progression-free survival (PFS) rate
Time Frame: at 12 weeks after randomization
Progression is defined as progressive disease (PD) by independent radiologic review according to RECIST criteria (version 1.1), termination of the assigned treatment, or death from any cause, assessed by Kaplan-Meier analysis and log-rank test for treatment comparisons with the intention-to-treat principle.
Secondary Outcomes
- Overall patient survival rate(up to 4 years after randomization)
- Progression-free survival (PFS) rate(at 24 weeks and up to 4 years after randomization)
- Radiologic response rate(at 12 and 24 weeks after randomization)
- treatment-crossover rate(at 12 and 24 weeks after randomization)
- time to progression(up to 4 years after randomization)
- Exploratory analysis for overall patient survival rate(up to 4 years after randomization)
Investigators
Young-Suk Lim
Professor
Asan Medical Center