NCT07204327Active, not recruiting
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 · Last updated 2 Oct 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 1136 (estimated)
- First submitted
- 24 Sept 2025
- Start date
- 28 Oct 2020
- Primary completion date
- 31 Oct 2025
- Lead sponsor
- Zhongda Hospital
- Diseases
- Liver and biliary tract cancer
- NCT number
- NCT07204327
What you commit to
- Study type: Observational
- Planned participants: 1136
- From 28 Oct 2020 to the primary completion date, 31 Oct 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior systemic therapy for HCC before Atezo+Bev initiation
- Concurrent participation in interventional clinical trials at baseline
Other illness
- Diagnosis of other malignancies at baseline (except basal cell carcinoma of the skin)
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Zhongda Hospital Southeast University Coordinator of this site? Confirm its status | Nanjing | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.