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Treatment for primary liver cancer – initial experience with a new device in a Brazilian Cancer Center

DEB TACE for intermediate and advanced hepatocellular carcinoma (HCC) – initial experience in a Brazilian Cancer Center

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN16295622
Enrollment
21
Registered
2016-10-14
Start date
2009-08-01
Completion date
Unknown
Last updated
2019-03-25

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

Conditions

Primary liver cancer Cancer

Interventions

The interventions (Procedures called DEB TACE - Transarterial chemoembolization with drug-eluting beads), were done by a staff member of the interventional radiology team with experience with oncology

Sponsors

INCA - Brazilian National Cancer Institute
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Patients 18 years old or above 2. Present with a Child A or B (Child-Pugh Classification) score 3. A PS equal or less than 2 4. A liver tumor compatible with a Barcelona clinic liver cancer (BCLC) stage B or C HCC which had not been previously submitted to transcatheter arterial chemoembolization (TACE) or any intra-arterial treatment

Exclusion criteria

Exclusion criteria: 1. Performance status scale (PS - Karnofsky performance status scale) of 2 or less 2. No extrahepatic spread of the liver tumor 3. Child-Pugh classification A or B 4. 17 years of age or younger 5. Refusal to sign the Informed consent

Design outcomes

Primary

MeasureTime frame
1. Tumor response, assessed via magnetic resonance imaging (MRI) or computed tomography (CT) if patient not able to withstand MRI 2. Progression-free survival, via clinical assessments performed at least every three months over a two year period

Secondary

MeasureTime frame
Toxicity, evaluated during the DEB TACE procedure, immediately after it and during hospital permanence. Assessed via telephone calls and regularly scheduled hospital patient visits over a two year period

Countries

Brazil

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 11, 2026