Clinical trial NCT01901692: Sorafenib vs.TransArterial Chemoembolization Plus RadioTherapy in Hepatocellular Carcinoma With Macrovascular Invasion
Official title: Randomized Trial Comparing Sorafenib and Transarterial Chemoembolization Plus External Beam Radiotherapy in Patients With Hepatocellular Carcinoma Showing Macroscopic Vascular Invasion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Hepatocellular Carcinoma
Keywords: liver cancer
first-line
tumor thrombus
vascular invasion
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
First posted: 2013-07-17
Enrollment: 90
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Progression-free survival (PFS) rate
timeFrame: at 12 weeks after randomization
Secondary outcomes:
measure: Progression-free survival (PFS) rate
timeFrame: at 24 weeks and up to 4 years after randomization
measure: Radiologic response rate
timeFrame: at 12 and 24 weeks after randomization
measure: treatment-crossover rate
timeFrame: at 12 and 24 weeks after randomization
measure: time to progression
timeFrame: up to 4 years after randomization
measure: Overall patient survival rate
timeFrame: up to 4 years after randomization
measure: Exploratory analysis for overall patient survival rate
timeFrame: up to 4 years after randomization
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
Study officials:
affiliation: Asan Medical Center
name: Young-Suk Lim, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Yoon SM, Ryoo BY, Lee SJ, Kim JH, Shin JH, An JH, Lee HC, Lim YS. Efficacy and Safety of Transarterial Chemoembolization Plus External Beam Radiotherapy vs Sorafenib in Hepatocellular Carcinoma With Macroscopic Vascular Invasion: A Randomized Clinical Trial. JAMA Oncol. 2018 May 1;4(5):661-669. doi: 10.1001/jamaoncol.2017.5847.