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Arsenic Trioxide TACE and Intravenous Administration in Unresectable Hepatocellular Carcinoma

NCT01861912 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 258

Last updated 2013-06-05

No results posted yet for this study

Summary

The purpose of this study is to determine whether compared with arsenic trioxide TACE alone, arsenic trioxide TACE and intravenous administration could further prolong the overall survival.

Conditions

  • Carcinoma, Hepatocellular

Interventions

DEVICE

Arsenic trioxide TACE

Arsenic trioxide powder 20mg dissolved in lipiodol(the dosage of lipiodol is decided according to the volume of the target lesion)is used for transcatheter arterial chemoembolization(TACE). TACE will be repeated after 4\~6 weeks if it is necessary according to the assessment from imaging modalities

DRUG

Arsenic trioxide intravenous infusion

Arsenic trioxide intravenous infusion: arsenic trioxide powder 0.15mg/Kg/d(maxim 10mg/d) dissolved in 250ml 0.9%NaCl solution is used for intravenous infusion.Every course will last for 3 weeks and the next course will be continued after 1 week suspension.Intravenous infusion will be suspended 3 days before and 7\~14 days after TACE.

DRUG

lipiodol

Lipiodol is used to dissolve arsenic trioxide for TACE,with the dosage decided according to the volume of the target lesion.

DRUG

NaCl solution

250ml NaCl solution is used to dissolve the arsenic trioxide for intravenous infusion.

Sponsors & Collaborators

  • Guangdong Provincial People's Hospital

    lead OTHER

Principal Investigators

  • Ligong Lu, Doctor · Guangdong Provincial People's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-06-30
Primary Completion
2016-06-30
Completion
2016-12-31

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01861912 on ClinicalTrials.gov