Cardiovascular and interventional radiology · 2026
Transarterial Embolization Alone Versus Drug-Eluting Microspheres Chemoembolization for Hepatocellular Carcinoma (RAD-18-TAcE): A Multicenter Randomized Clinical Trial.
СтатьяРандомизированное исследованиеМногоцентровое исследованиеСравнительное исследованиеEquivalence TrialНазвание и аннотация: Перевод пока не подготовлен
Обработка статьи · этапы, ошибки и управление
Загрузка состояния…
Ошибки и ограничения
История · было → стало
Состояние обновляется каждые 5 секунд, пока блок открыт. Процент показывается только там, где известен объём работы. Пауза останавливает продолжение этапа; текущий запрос к источнику может завершиться.
Mosconi Cristina, Taninokuchi Tomassoni Makoto, Zanella Sara, Paccapelo Alexandro, Marasco Giovanni, Gusmini Simone, Ratti Francesca, Palumbo Diego, Sironi Sandro, Muglia Riccardo, Fronda Marco Mario Edgardo, Calandri Marco, Fonio Paolo, Marra Paolo, Doriguzzi Breatta Andrea, Cucchetti Alessandro, De Cobelli Francesco, Renzulli Matteo
Аннотация
PURPOSE: To compare transarterial embolization (TAE) and drug-eluting microspheres transarterial chemoembolization (DEM-TACE) in the treatment of hepatocellular carcinoma (HCC) through a non-inferiority randomized clinical trial.
MATERIALS AND METHODS: Patients diagnosed with unresectable HCC were randomly assigned to either the TAE or DEM-TACE group. The primary endpoint was time to progression (TTP), and secondary endpoints included overall survival, hospitalization stay, tumor response rates, and severe adverse events (SAE).
RESULTS: At the end of the trial, a total of 111 patients (56 TAE and 55 DEM-TACE) were enrolled between 2019 and 2022. The median TTP was similar between TAE and DEM-TACE (7.56 vs. 7.98 months, p = 0.432). In patients with confirmed disease progression, the mean TTP was 6.68 vs. 8.43 months for TAE and DEM-TACE, respectively, with a mean difference of 1.75 months (95% CI - 1.47-4.97), falling within the predefined equivalence range; two one side test (TOST) analysis confirmed equivalence (p < 0.001 and p = 0.022 for lower and upper bounds. Overall survival, tumor response rates, and adverse events were also not statistically different between groups (p > 0.05 for each outcome). Finally, Days of hospitalization were not statistically different (median 4 days for both arms, p = 0.638).
CONCLUSION: TAE and DEM-TACE had comparable results in the treatment of early and intermediate stage unresectable HCC.
MATERIALS AND METHODS: Patients diagnosed with unresectable HCC were randomly assigned to either the TAE or DEM-TACE group. The primary endpoint was time to progression (TTP), and secondary endpoints included overall survival, hospitalization stay, tumor response rates, and severe adverse events (SAE).
RESULTS: At the end of the trial, a total of 111 patients (56 TAE and 55 DEM-TACE) were enrolled between 2019 and 2022. The median TTP was similar between TAE and DEM-TACE (7.56 vs. 7.98 months, p = 0.432). In patients with confirmed disease progression, the mean TTP was 6.68 vs. 8.43 months for TAE and DEM-TACE, respectively, with a mean difference of 1.75 months (95% CI - 1.47-4.97), falling within the predefined equivalence range; two one side test (TOST) analysis confirmed equivalence (p < 0.001 and p = 0.022 for lower and upper bounds. Overall survival, tumor response rates, and adverse events were also not statistically different between groups (p > 0.05 for each outcome). Finally, Days of hospitalization were not statistically different (median 4 days for both arms, p = 0.638).
CONCLUSION: TAE and DEM-TACE had comparable results in the treatment of early and intermediate stage unresectable HCC.