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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02038296
Enrollment
162
Registered
2014-01-16
Start date
2008-01-31
Completion date
2013-03-31
Last updated
2014-01-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Liver Cancer

Keywords

Hepatocellular carcinoma, Transarterial chemoembolization, Gemcitabine

Brief summary

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

Interventions

PROCEDUREtransarterial chemoembolization

Sponsors

Guangdong Provincial People's Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
overall survival1-2 year

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026