Clinical trial · Observational
Peripheral Blood Biomarkers and Response to Atezolizumab Plus Bevacizumab in Hepatocellular Carcinoma
Peripheral Blood Biomarkers for Predicting Response to Atezolizumab Plus Bevacizumab in Hepatocellular Carcinoma: A Single-Center Prospective Observational Cohort 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)
This single-center prospective observational cohort study aims to evaluate the predictive value of peripheral blood-based biomarkers for treatment response in patients with hepatocellular carcinoma (HCC) receiving first-line atezolizumab plus bevacizumab (T+A) therapy. Residual peripheral blood samples obtained during routine clinical testing will be analyzed without additional blood draws. The study hypothesizes that baseline and longitudinal peripheral blood biomarkers are associated with treatment response and can be used to identify patients more likely to benefit from T+A therapy. Treatment response will be evaluated based on the best overall response (BOR) during treatment. The primary efficacy assessment will be performed according to RECIST 1.1, while modified RECIST (mRECIST) will be used as a supportive assessment. Predictive models based on peripheral blood biomarkers will be developed using RECIST 1.1-defined treatment response as the primary analysis, with mRECIST used for supportive and sensitivity analyses.
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 (HCC) | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| No intervention (observational study) | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Objective Response Rate
- timeFrame
- From treatment initiation up to 12 months.
- description
- Objective response rate, defined as the proportion of participants achieving CR or PR according to RECIST 1.1 based on the BOR during T+A therapy.
Secondary outcomes (4)
- measure
- Baseline Peripheral Blood Biomarker Concentrations
- timeFrame
- Baseline (within 7 days before treatment initiation).
- description
- Baseline concentrations of predefined peripheral blood biomarkers measured using ELISAs will be assessed before treatment initiation.
- measure
- Change From Baseline in Peripheral Blood Biomarker Concentrations
- timeFrame
- Baseline and approximately every 3 weeks during treatment, up to 12 months.
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available