Sorafenib vs.TransArterial Chemoembolization Plus RadioTherapy in Hepatocellular Carcinoma With Macrovascular Invasion

Hepatocellular Carcinoma Clinical Trial

— START  

Official title:

Randomized Trial Comparing Sorafenib and Transarterial Chemoembolization Plus External Beam Radiotherapy in Patients With Hepatocellular Carcinoma Showing Macroscopic Vascular Invasion

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01901692
• Other study ID #: AMC IRB 2013-0627
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: July 14, 2013
• Last updated: September 15, 2017
• Start date: July 29, 2013
• Est. completion date: August 31, 2017

Study information

• Verified date: September 2017
• Source: Asan Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: August 31, 2017
• Est. primary completion date: January 20, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

Radiation:
• TACE+External beam RT
Trans-arterial chemoembolization (TACE) every 6 weeks + external beam radiation therapy starting within 3 weeks after first TACE

Drug:
• Sorafenib
Sorafenib 800 mg/day orally

Locations

Country	Name	City	State
Korea, Republic of	Asan Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Asan Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free survival (PFS) rate	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.	at 12 weeks after randomization
Secondary	Progression-free survival (PFS) rate	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.	at 24 weeks and up to 4 years after randomization
Secondary	Radiologic response rate	Radiologic response rate by independent radiologic review according to RECIST criteria (version 1.1), , assessed by Chi-square test or Fisher's exact test, as appropriate.	at 12 and 24 weeks after randomization
Secondary	treatment-crossover rate	Crossover of treatment is permitted after confirming the disease progression during the initially assigned treatment, assessed by Kaplan-Meier analysis and log-rank test for treatment comparisons.	at 12 and 24 weeks after randomization
Secondary	time to progression	The median time to progression assessed by Kaplan-Meier analysis and log-rank test for treatment comparisons.	up to 4 years after randomization
Secondary	Overall patient survival rate	The median overall patient survival rate assessed by Kaplan-Meier analysis and log-rank test for treatment comparisons.	up to 4 years after randomization
Secondary	Exploratory analysis for overall patient survival rate	By using Cox proportional hazards model to evaluate the interaction between important baseline characteristics and the effect of treatments on overall survival.	up to 4 years after randomization