NCT01901692

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P75+ for phase_2 hepatocellular-carcinoma

Timeline
Completed

Started Jul 2013

Typical duration for phase_2 hepatocellular-carcinoma

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 14, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 17, 2013

Completed
12 days until next milestone

Study Start

First participant enrolled

July 29, 2013

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 20, 2017

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2017

Completed
Last Updated

September 18, 2017

Status Verified

September 1, 2017

Enrollment Period

3.5 years

First QC Date

July 14, 2013

Last Update Submit

September 15, 2017

Conditions

Hepatocellular Carcinoma

Keywords

liver cancerfirst-linetumor thrombusvascular invasion

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • 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

  • Overall patient survival rate

    up to 4 years after randomization

  • +1 more secondary outcomes

Study Arms (2)

TACE+External beam RT

EXPERIMENTAL

Transarterial chemoembolization plus external beam radiation therapy

Radiation: TACE+External beam RT

Sorafenib

ACTIVE COMPARATOR

Sorafenib 800 mg/day orally

Drug: Sorafenib

Interventions

TACE+External beam RTRADIATION

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

TACE+External beam RT
SorafenibDRUG

Sorafenib 800 mg/day orally

Also known as: Nexavar
Sorafenib

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asan Medical Center

Seoul, 05505, South Korea

Location

Related Publications (1)

  • 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.

    PMID: 29543938DERIVED

MeSH Terms

Conditions

Carcinoma, HepatocellularLiver Neoplasms

Interventions

Sorafenib

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Intervention Hierarchy (Ancestors)

Phenylurea CompoundsUreaAmidesOrganic ChemicalsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsNiacinamideNicotinic AcidsAcids, HeterocyclicHeterocyclic CompoundsPyridinesHeterocyclic Compounds, 1-Ring

Study Officials

  • Young-Suk Lim, MD, PhD

    Asan Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 14, 2013

First Posted

July 17, 2013

Study Start

July 29, 2013

Primary Completion

January 20, 2017

Study Completion

August 31, 2017

Last Updated

September 18, 2017

Record last verified: 2017-09

Locations

KR(1)