NCT07824765Not yet recruiting
Heterogeneity of Treatment Effects of Adding Locoregional Therapies to Atezolizumab Plus Bevacizumab in Patients With Unresectable Hepatocellular Carcinoma (ISMIO-026)
Heterogeneity of Treatment Effects of Adding Locoregional Therapies to Atezolizumab Plus Bevacizumab in Patients With Unresectable Hepatocellular Carcinoma Based on Clinical and Multiregional, Multiphase Contrast-Enhanced CT/MRI Features (ISMIO-026)
Source: ClinicalTrials.gov · Last updated 17 Sept 2026
Brief summary (registry, in English)
uHCC imposes a substantial disease burden in China and the Asia-Pacific region. Atezo+Bev is an important first-line regimen for patients who have not received prior systemic therapy; however, not all patients achieve adequate and durable tumor control. In clinical practice, ablation, radiotherapy, or transarterial therapy is often added to Atezo+Bev to intensify intrahepatic disease control. The indications, timing, efficacy, and risk of liver-function impairment vary across LRTs. Most existing studies report average treatment effects and often use TACE as a fixed backbone, and therefore do not directly identify which patients receiving Atezo+Bev should receive early LRTs. Using target trial emulation and HTE analysis, this study will integrate baseline clinical variables with pretreatment contrast-enhanced CT/MRI features to estimate the CATE of early LRT initiation and identify patients likely to achieve greater survival benefit.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 2658 (estimated)
- First submitted
- 1 Sept 2026
- Start date
- 1 Sept 2026
- Primary completion date
- 1 Sept 2027
- Lead sponsor
- Zhongda Hospital
- Diseases
- Liver and biliary tract cancer
- NCT number
- NCT07824765
What you commit to
- Study type: Observational
- Planned participants: 2658
- From 1 Sept 2026 to the primary completion date, 1 Sept 2027
- 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
- Suitability for immediate curative resection or liver transplantation following multidisciplinary assessment.
Other illness
- Another primary malignancy requiring active systemic treatment on the index date, except for a malignancy that has been cured and has a low risk of recurrence.
- Active autoimmune disease or immunodeficiency requiring systemic immunosuppression or constituting a contraindication to atezolizumab.
- Inadequately controlled high-risk esophageal/gastric varices, recent variceal bleeding, an uncorrected bleeding tendency, or clinically significant coagulopathy.
Other
- Participation on the index date in an interventional study that could affect treatment allocation or outcome assessment.
- An absolute contraindication to Atezo+Bev or to all feasible LRTs.
- Inability to determine the index date, primary treatment strategy, OS outcome/censoring date, or absence of a technically adequate baseline contrast-enhanced CT/MRI examination.
Who the study is looking for
- Age ≥18 years on the index date.
- Receipt of at least one dose each of atezolizumab and bevacizumab as part of the same first-line combination regimen, with an interval of ≤28 days between the first administrations of the two drugs.
- At least one intrahepatic lesion amenable to a protocol-specified LRT on the index date, with no absolute contraindication to Atezo+Bev or to all feasible LRTs.
- A clinical, radiologic, or pathologic diagnosis of uHCC on or before the index date; baseline EHS is permitted.
- Survival status or the date last known alive after the index date can be ascertained.
- No systemic therapy for HCC before the regimen initiation date.
- No LRT within 60 days before the index date or between baseline imaging and the index date; earlier prior LRTs are permitted provided that an untreated, measurable intrahepatic lesion remains.
- A technically adequate baseline contrast-enhanced CT/MRI examination and at least one untreated intrahepatic lesion that can be delineated and evaluated.
- Baseline ECOG performance status of 0-2.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Zhongda Hospital Coordinator of this site? Confirm its status | Nanjing | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.