NCT07091942Befejeződött
Curative Therapy After Atezolizumab and Bevacizumab Treatment for Unresectable Hepatocellular Carcinoma
Curative Therapy After Atezolizumab and Bevacizumab Treatment for Unresectable Hepatocellular Carcinoma: A Multinational Retrospective Study
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. okt. 9.
Rövid összefoglaló (regiszter, angolul)
Combination immunotherapy is currently the standard first-line systemic treatment for unresectable hepatocellular carcinoma (HCC). Approximately 30 % of patients treated with atezolizumab plus bevacizumab (Atezo-Bev) achieve complete or partial tumor response. Some patients who reach a partial response experience enough tumor regression to undergo curative therapies and subsequently attain a disease-free state. However, whether the prognosis of patients who become disease-free after curative therapy equals that of patients who achieve complete response with Atezo-Bev alone is unclear. Likewise, it remains uncertain whether patients who achieve partial response with Atezo-Bev and later undergo curative therapy fare better than those who remain in partial response without further curative treatment. Therefore, we designed this multinational, multicenter, retrospective chart-review study to address these questions. Planned Cohorts * Curative-therapy cohort: Patients with unresectable HCC who achieve partial response to Atezo-Bev and subsequently receive curative therapy-surgical resection, radiofrequency ablation, or definitive radiotherapy-to achieve a disease-free state. * Control cohort: Patients with unresectable HCC who achieve complete or partial response to Atezo-Bev but do not undergo subsequent curative therapy. Methods and End-points Data will be collected from no more than 30 hospitals worldwide, targeting roughly 400 patients in the curative-therapy cohort and 1,200 patients in the control cohort. Medical-record review will gather baseline characteristics, disease status, liver function, Atezo-Bev treatment details, curative-therapy specifics, treatment responses, and survival outcomes. The primary objective is to compare recurrence-free survival between the two cohorts. This retrospective study will close data collection on 31 March 2025.
- Állapot (regiszter)
- Befejeződött
- Vizsgálattípus
- Megfigyeléses
- Résztvevők száma
- 243 (tényleges)
- Első benyújtás
- 2025. júl. 17.
- Kezdés
- 2025. júl. 17.
- Elsődleges befejezés
- 2026. okt. 8.
- Fő szponzor
- National Taiwan University Hospital
- Betegségek
- Gyermekkori daganatok, Máj- és epeúti rák
- NCT-szám
- NCT07091942
Mit vállalsz
- Vizsgálat típusa: Megfigyeléses
- Bevont résztvevők: 243
- 2025. júl. 17. és az elsődleges befejezés (2026. okt. 8.) között
- 1 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálat felépítését írja le.
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Korábbi kezelés
- Received anti-CTLA4 antibodies simultaneously with Atezo-Bev Patients who received Atezo-Bev in combination with investigational drugs such as tiragolumab, relatlimab, and tocilizumab were allowed to enter the study.
- Received locoregional therapy simultaneously with Atezo-Bev treatment, such as transarterial chemoembolization (TACE), hepatic arterial infusion of chemotherapy (HAIC), transarterial radioembolization, radiofrequency ablation, and microwave ablation before obtaining PR or not for curative intent
Egyéb
- Fibrolamellar carcinoma or mixed hepatocellular cholangiocarcinoma.
Kiket keres a vizsgálat
- Histologically or clinically (the presence of liver cirrhosis and typical HCC imaging findings by multi-phase CT or MRI) diagnosed HCC.
- Received Atezo-Bev containing treatment as first-line systemic therapy for HCC
- Patients with or without macrovascular invasion and main portal vein invasion before Atezo-Bev containing treatment can be enrolled
- Patients with or without extrahepatic spread before Atezo-Bev containing treatment can be enrolled
- Obtained CR or PR, according to RECIST version 1.1, to Atezo-Bev treatment
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Helyszínek (1)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| National Taiwan University Hospital | Taipei | Tajvan | Ismeretlen állapot |
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