Carcinoma, Hepatocellular Clinical Trial
Official title:
Endoarterial Treatment in Combination With Percutaneous Thermoablation for Medium-sized and Oligonodular Hepatocellular Carcinomas
| NCT number | NCT04172194 |
| Other study ID # | 19-PT-02 |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | January 1, 2009 |
| Est. completion date | December 31, 2014 |
| Verified date | November 2019 |
| Source | Centre Hospitalier Universitaire de Nice |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
Background: The association of transcatheter arterial chemotherapy infusion (TAC) with
percutaneous ablation (PT) has been introduced as a method to increase the ablative zone. The
aim of this study was to evaluate the efficacy of PT and TAC performed in a single session
for HCCs between 30 and 50 mm or oligonodular up to 30 mm.
Methods: Thirty patients with a histologically proven HCC, uninodular between 30 and 50 mm or
oligonodular (n≤3) up to 30 mm, treatment-naïve and non-metastatic, received combination
treatment ("PT+TAC group"). A "control" group consisted of 34 patients with uninodular HCC up
to 30 mm without any poor prognostic criteria treated with PT alone ("PT group").
| Status | Completed |
| Enrollment | 64 |
| Est. completion date | December 31, 2014 |
| Est. primary completion date | December 31, 2014 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 19 Years and older |
| Eligibility |
Inclusion Criteria: - hepatocellular carcinoma pouved by pathology, Exclusion Criteria: - metastases |
| Country | Name | City | State |
|---|---|---|---|
| France | Nice Hospital | Nice |
| Lead Sponsor | Collaborator |
|---|---|
| Centre Hospitalier Universitaire de Nice |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | overall survival | death | 30 minutes | |
| Secondary | relapse free survival | relapse | 30 minutes | |
| Secondary | tolerance | apparition of complication define by CTCAE v5.0 | 30 minutes |
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