Peripheral Blood Biomarkers and Response to Atezolizumab Plus Bevacizumab in Hepatocellular Carcinoma

NCT07734857 | Not Yet Recruiting

• 1 other identifier: B2026-234R
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Hepatocellular Carcinoma (HCC)

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate

  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.

  From treatment initiation up to 12 months.

Secondary Outcomes (4)

• Baseline Peripheral Blood Biomarker Concentrations

  Baseline (within 7 days before treatment initiation).

• Change From Baseline in Peripheral Blood Biomarker Concentrations

  Baseline and approximately every 3 weeks during treatment, up to 12 months.

• Progression-Free Survival

  From treatment initiation up to 12 months.

• Overall Survival

  From treatment initiation up to 12 months.

Interventions

No intervention (observational study) OTHER

No intervention (observational study)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients with histologically or clinically confirmed unresectable or advanced HCC who are scheduled to receive first-line atezolizumab plus bevacizumab therapy at Zhongshan Hospital, Fudan University.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead

Biospecimen

Retention: SAMPLES WITHOUT DNA

When available, residual peripheral blood samples obtained during routine clinical blood testing will be collected at baseline (within 7 days before treatment initiation), at routine treatment visits approximately every 3 weeks, and at the first documented disease progression. No additional blood draws will be performed specifically for research purposes.

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Observation

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2026
• First Posted: July 29, 2026
• Study Start: July 10, 2026
• Primary Completion (Estimated): July 10, 2028
• Study Completion (Estimated): July 30, 2028
• Last Updated: July 29, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share