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OpenTrials
Completed

NCT Number: NCT02038296

Different Protocols for Repeated Transarterial Chemoembolization in the Treatment of Patients With Hepatocellular Carcinoma

To evaluate local tumor control and survival rate after repeated transarterial chemoembolization(TACE) using three different protocols in hepatocellular carcinoma (HCC) patients.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Department of Interventional Radiology; Cancer Center; Guangdong General Hospital

Guangzhou, Guangdong, 510080, China

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients with histologically confirmed HCC with unresectable disease without extrahepatic metastases;
  • HCC with no previous treatment;
  • age between 18 and 75 years;
  • Life expectancy of at least 8 weeks;
  • main tumor size greater than 5 cm;
  • adequate hematologic function (platelet count: >60 × 109 platelets/L; hemoglobin: >90g/L; and prothrombin time: <3 seconds above control);
  • adequate renal function (serum creatinine: ≤1.5 × upper limit of normal);
  • Child-Pugh classification A or B grade;
  • Barcelona Clinic Liver Cancer (BCLC) stage B or C;
  • Eastern Co-operative Group performance status of zero or one.

Exclusion criteria

  • a hypovascular tumor (defined as a tumor with all its parts less contrast-enhanced than the nontumorous liver parenchyma on arterial phase computed tomography scans);
  • diffuse-type HCC;
  • evidence of hepatic decompensation including esophageal or gastric variceal bleeding or hepatic encephalopathy;
  • severe underlying cardiac or renal diseases;
  • color Doppler ultrasonography showing portal vein tumor thrombosis with complete main portal vein obstruction without cavernous transformation; or obstructive jaundice.

Treatment and study plan

Transarterial chemoembolization

Procedure

Primary outcomes

  1. overall survival

    Time frame: 1-2 year

Sponsors and collaborators

Lead sponsor

Guangdong Provincial People's Hospital

Other

Registry information

Important dates

Study start
2008
Primary completion
2013
Study completion
2013
First posted
Jan 16, 2014
Registry last updated
Jan 17, 2014

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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