Clinical trial · Interventional
A Study of TACE Combined With Atezolizumab Plus Bevacizumab or TACE Alone in Patients With Untreated Heaptocellular Carcionma
A Phase III, Open-Label, Randomized Study of On-Demand TACE Combined With Atezolizumab Plus Bevacizumab (Atezo/Bev) or On-Demand TACE Alone in Patients With Untreated Heaptocellular Carcionma
NCT04712643CI-TRIAL-00119757active not recruitingPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study will evaluate the efficacy and safety of atezolizumab plus bevacizumab combined with on-demand TACE compared to on-demand TACE alone in participants with hepatocellular carcinoma who are at high risk of poorer outcome following TACE treatment.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hepatocellular Carcinoma | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Atezolizumab | Drug | Atezolizumab | ALIAS |
| Becavizumab | Drug | — | UNRESOLVED |
| Transarterial chemoembolization (TACE) | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm A: atezolizumab + bevacizumab + TACE
- description
- Participants will receive atezolizumab plus bevacizumab on Day 1 of a 21-Day cycle, after every on-demand transarterial chemoembolization procedure.
- interventionNames
- Drug: Atezolizumab
- Drug: Becavizumab
- Device: Transarterial chemoembolization (TACE)
- type
- ACTIVE_COMPARATOR
- label
- Arm B: TACE alone
- description
- Participants will receive on-demand transarterial chemoembolization.
- interventionNames
- Device: Transarterial chemoembolization (TACE)
Primary outcomes (2)
- measure
- TACE Progression-Free Survival (TACE PFS) as Determined by Investigator
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Confirmed diagnosis of HCC by histology/ cytology or clinical criteria * Eligible for TACE treatment * No prior systemic therapy for HCC, especially immunotherapy * No prior locoregional therapy to the target lesion(s) * At least one measurable untreated lesion * ECOG Performance Status of 0-1 * Child-Pugh class A Exclusion Criteria: * Evidence of Vp3/4 and hepatic vein tumor thrombus (HVTT) * Evidence of extrahepatic spread (EHS) * Being a candidate for curative treatments * Any condition representing a contraindication to TACE as determined by the investigators * Active or history of autoimmune disease or immune deficiency * Untreated or incompletely treated esophageal and/or gastric varices with bleeding or high risk for bleeding * A prior bleeding event due to esophageal and/or gastric varices within 6 months prior to initiation of study treatment * Evidence of bleeding diathesis or significant coagulopathy
References
Publications (1)
- DERIVEDKudo M, Ogasawara S, Liu R, Gu S, Wang K, Zhao M, Hu H, Liu Z, Lin K, Liu J, Lin Z, Zhang Y, Peng T, Song J, Ueno M, Zhu J, Bai L, Tong L, Shi Y, Han G, Dong J. On-demand transarterial chemoembolisation combined with atezolizumab and bevacizumab in patients with untreated hepatocellular carcinoma (TALENTACE): a multicentre, randomised, open-label, phase 3 trial. Lancet Gastroenterol Hepatol. 2026 Aug 25:S2468-1253(26)00212-8. doi: 10.1016/S2468-1253(26)00212-8. Online ahead of print. PMID 42641632