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Completed

NCT Number: NCT01901692

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

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

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Key information

Conditions

Hepatocellular Carcinoma Adenocarcinoma Carcinoma Carcinoma, Hepatocellular Digestive System Diseases Digestive System Neoplasms Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Asan Medical Center

Seoul, 05505, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TACE+External beam RT

Radiation

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

Sorafenib

Drug

Sorafenib 800 mg/day orally

Other names: Nexavar

Primary outcomes

  1. 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

  1. Progression-free survival (PFS) rate

    Time frame: at 24 weeks and up to 4 years 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.

  2. Radiologic response rate

    Time frame: at 12 and 24 weeks after randomization

    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.

  3. treatment-crossover rate

    Time frame: at 12 and 24 weeks after randomization

    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.

  4. time to progression

    Time frame: up to 4 years after randomization

    The median time to progression assessed by Kaplan-Meier analysis and log-rank test for treatment comparisons.

  5. Overall patient survival rate

    Time frame: up to 4 years after randomization

    The median overall patient survival rate assessed by Kaplan-Meier analysis and log-rank test for treatment comparisons.

  6. Exploratory analysis for overall patient survival rate

    Time frame: up to 4 years after randomization

    By using Cox proportional hazards model to evaluate the interaction between important baseline characteristics and the effect of treatments on overall survival.

Sponsors and collaborators

Lead sponsor

Asan Medical Center

Other

Registry information

Official study title

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

Acronym: START

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Jul 17, 2013
Registry last updated
Sep 18, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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