Clinical trial · Observational
Atezolizumab Plus Bevacizumab Versus Sintilimab Plus Bevacizumab With TACE and HAIC in Unresectable Hepatocellular Carcinoma
Atezolizumab Plus Bevacizumab Versus Sintilimab Plus Bevacizumab With Transarterial Chemoembolization and Hepatic Arterial Infusion Chemotherapy in Unresectable Hepatocellular Carcinoma: A Multicenter Real-World Study
- 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)
Systemic therapy is the primary option for managing advanced hepatocellular carcinoma (HCC). The combination of atezolizumab and bevacizumab (A+B) has emerged as the first-choice treatment for advanced HCC(IM brave 150). The ORIENT-32 study, also reported an ORR of 24% for sintilimab plus a bevacizumab biosimilar (S+B) versus 8% for sorafenib, with significantly longer OS and PFS. Based on those therapeutic advantages over sorafenib, both the A+B and S+B regimens were approved as first-line treatment options for advanced HCC in China. These two trials had very similar designs but included different target populations. Our previous studies have demonstrated that a novel treatment approach combining transarterial chemoembolization (TACE) with hepatic arterial infusion chemotherapy (HAIC) has high efficacy in patients with potentially resectable HCC or portal vein tumor thrombus. However, it remains unknown whether combining immune checkpoint inhibitors and macromolecular VEGF-targeted therapy with transvascular local interventions could improve patient prognosis in uHCC.
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 combined with Bevacizumab | Drug | — | UNRESOLVED |
| Sintilimab combined with Bevacizumab | Drug | — | UNRESOLVED |
| Transcatheter arterial chemoembolization and hepatic arterial infusion chemotherapy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- ABTH
- description
- Atezolizumab plus bevacizumab combined with TACE-HAIC
- interventionNames
- Drug: Atezolizumab combined with Bevacizumab
- Procedure: Transcatheter arterial chemoembolization and hepatic arterial infusion chemotherapy
- label
- SBTH
- description
- Sintilimab plus bevacizumab combined with TACE-HAIC
- interventionNames
- Drug: Sintilimab combined with Bevacizumab
- Procedure: Transcatheter arterial chemoembolization and hepatic arterial infusion chemotherapy
Primary outcomes (2)
- measure
- objective response rate,ORR
- timeFrame
- 24 months
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * (a) a confirmed diagnosis of uHCC; * (b) at least one target lesion evaluable by both RECIST 1.1 and mRECIST criteria; * (c) Child-Pugh Grade A or B. Exclusion Criteria: * (a) previous exposure to other anti-cancer treatments; * (b) diagnosis of any other primary malignancy; * (c) significant esophageal varices or observable red wale marks; * (d) a history of severe cardiac, pulmonary, or renal comorbidities; * (e) incomplete follow-up records.
References
Publications (0)
Data not yet available