Clinical trial · Observational
Atezolizumab Plus Bevacizumab Combined With Locoregional Therapies in Unresectable Hepatocellular Carcinoma (ISMIO-001)
Effectiveness and Safety of Atezolizumab + Bevacizumab Plus Locoregional Therapies in Patients With Unresectable Hepatocellular Carcinoma in Real-world Clinical Practice
- 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 is a retrospective, multicenter, real-world cohort study designed to evaluate the effectiveness and safety of atezolizumab plus bevacizumab (Atezo+Bev) combined with various locoregional therapies (LRTs), including transarterial chemoembolization (TACE), hepatic arterial infusion chemotherapy (HAIC), transarterial radioembolization (TARE), ablation, and radiotherapy, in patients with unresectable hepatocellular carcinoma (uHCC). Approximately 1,136 patients treated between October 28, 2020 and October 31, 2025 will be included from about 35 sites across China and the Asia-Pacific region. The primary endpoint is overall survival (OS). Secondary endpoints include real-world progression-free survival (rwPFS), overall response rate (ORR), disease control rate (DCR), time to discontinuation (TTD), time to next treatment (TTNT), time to progression (TTP), and safety outcomes. Exploratory analyses will assess associations between baseline patient characteristics, treatment patterns, and clinical outcomes.
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 |
|---|---|---|---|
| Unresectable Hepatocellular Carcinoma | Hepatocellular Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Atezo+Bev plus Locoregional Therapy | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- uHCC patients treated with Atezo+Bev plus LRT
- description
- Patients with unresectable hepatocellular carcinoma (uHCC) who received first-line atezolizumab plus bevacizumab (Atezo+Bev) in combination with at least one locoregional therapy (TACE, HAIC, TARE, ablation, or radiotherapy) within ±2 months of systemic therapy initiation, between October 28, 2020 and July 31, 2025.
- interventionNames
- Other: Atezo+Bev plus Locoregional Therapy
Primary outcomes (1)
- measure
- Overall Survival (OS)
- timeFrame
- Up to 36 months (median follow-up period anticipated)
- description
- Overall survival, defined as the time from initiation of atezolizumab plus bevacizumab treatment to death from any cause.
Secondary outcomes (7)
- measure
- Real-world Progression-Free Survival (rwPFS)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age ≥18 years at initiation of atezolizumab plus bevacizumab (Atezo+Bev) * Histologically or radiologically confirmed unresectable hepatocellular carcinoma (uHCC) according to national guidelines * Initiated first-line Atezo+Bev treatment between October 28, 2020 and July 31, 2025 * Received ≥1 locoregional therapy (TACE, HAIC, TARE, ablation, or radiotherapy) within ±2 months of Atezo+Bev initiation * At least one follow-up record available after treatment initiation Exclusion Criteria: * Prior systemic therapy for HCC before Atezo+Bev initiation * Concurrent participation in interventional clinical trials at baseline * Diagnosis of other malignancies at baseline (except basal cell carcinoma of the skin)
References
Publications (0)
Data not yet available