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

NCT ID: NCT01901692

Last Updated: 2017-09-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-07-29

Study Completion Date

2017-08-31

Brief Summary

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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

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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.

Conditions

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Hepatocellular Carcinoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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TACE+External beam RT

Transarterial chemoembolization plus external beam radiation therapy

Group Type EXPERIMENTAL

TACE+External beam RT

Intervention Type RADIATION

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

Sorafenib

Sorafenib 800 mg/day orally

Group Type ACTIVE_COMPARATOR

Sorafenib

Intervention Type DRUG

Sorafenib 800 mg/day orally

Interventions

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TACE+External beam RT

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

Intervention Type RADIATION

Sorafenib

Sorafenib 800 mg/day orally

Intervention Type DRUG

Other Intervention Names

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Nexavar

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Asan Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Young-Suk Lim

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Young-Suk Lim, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Asan Medical Center

Locations

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Asan Medical Center

Seoul, , South Korea

Site Status

Countries

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South Korea

References

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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.

Reference Type DERIVED
PMID: 29543938 (View on PubMed)

Other Identifiers

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AMC IRB 2013-0627

Identifier Type: -

Identifier Source: org_study_id