Blood biomarkers to predict response to atezolizumab plus bevacizumab in hepatocellular carcinoma
Official title: Peripheral Blood Biomarkers for Predicting Response to Atezolizumab Plus Bevacizumab in Hepatocellular Carcinoma: A Single-Center Prospective Observational Cohort Study
Run by Shanghai Zhongshan Hospital · NCT07734857 · Data updated 2026-11-12
This study tests whether blood-based biomarkers can predict which patients with advanced liver cancer will respond to first-line atezolizumab plus bevacizumab.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 80 Years |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | Shanghai Zhongshan Hospital Academic / other |
| Drugs / interventions | atezolizumab, bevacizumab |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Status | Recruiting |
| Started | September 1, 2026 |
| Main results expected | July 10, 2028 |
| Study ends | July 30, 2028 |
| Registry record updated | November 10, 2026 |
| Trial ID | NCT07734857 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18–80 with unresectable or advanced hepatocellular carcinoma planned to start first-line atezolizumab plus bevacizumab and with measurable disease.
✕Probably not a fit
Patients who do not exhibit biomarker patterns associated with response or those without analyzable baseline/longitudinal samples may not derive predictive benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a single-center prospective observational cohort study enrolling patients with unresectable or advanced hepatocellular carcinoma who are starting first-line atezolizumab plus bevacizumab. Researchers will analyze baseline and longitudinal peripheral blood samples collected during routine clinical testing to explore proteomic, metabolomic, extracellular vesicle, and cell-based biomarkers. The goal is to see if these biomarkers correlate with treatment response as measured by RECIST 1.1 (with mRECIST as a supportive assessment) and to develop predictive models that identify likely responders. No experimental intervention is performed; the study relies on residual blood samples and standard clinical data collected during care. Eligible participants will be enrolled at Zhongshan Hospital, Fudan University, with analyses focused on predicting treatment benefit from T+A therapy.
Why it matters
Potential benefit: If successful, the biomarkers could help tailor therapy by identifying patients most likely to benefit from T+A and sparing others from ineffective treatment.
How similar studies have gone: Biomarker-based prediction has shown promise in some cancers, but robust, validated predictors for T+A response in HCC remain limited, making this investigation relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age 18-80 years * Histologically or clinically confirmed unresectable or advanced HCC, classified according to the BCLC staging system * Planned to receive first-line atezolizumab plus bevacizumab therapy, with no prior systemic therapy for unresectable or advanced HCC * At least one measurable target lesion with a longest diameter of ≥10 mm on CT or MRI according to RECIST 1.1, with mRECIST assessment performed when applicable * Availability of baseline and follow-up clinical and radiological data * Willing and able to provide written informed consent Exclusion Criteria: * Presence of another active malignancy, except for malignancies that have been curatively treated and remain recurrence-free * Prior systemic treatment with immune checkpoint inhibitors or anti-angiogenic agents for unresectable or advanced HCC * Expected inability to complete the required clinical or radiological follow-up assessments * Severe comorbid conditions that may interfere with study participation * No qualified residual blood sample available for planned biomarker analyses because of insufficient volume, contamination, loss, or other sample-related issues * Any condition deemed unsuitable for participation by the investigator
Where it's running
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Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, China Recruiting
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.