Risk of Reactivation of Occult Hepatitis B in Cancer Patients During Immunotherapy.

December 18, 2025 updated by: Angioletta Lasagna, Fondazione IRCCS Policlinico San Matteo di Pavia

Novel HBV Biomarkers to Assess the Risk of Reactivation of Occult Hepatitis B in Cancer Patients During Immunotherapy: an Observational Prospective Multicenter Study.

The goal of this observational study is to evalue the cumulative proportion of patients with OBI who do not develop HBsAg seroreversion and/or an increase of serum HBV DNA by at least 1 log above the lower limit of detection of the assay in a patient who had previously undetectable HBsAg and HBV DNA in serum during the study.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • PV
      • Pavia, PV, Italy, 27100
        • Irccs San Matteo Pavia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with solid tumors who have an occult hepatitis B infection and who need to start immunotherapy treatment.

Description

Inclusion Criteria:

  • Life-expectancy (as estimated by treating physician) ≥ 6 months;
  • Patients HBsAg negative
  • Patients HBcAb positive with or without HBV-DNA detectable
  • Patients with cancer undergoing immunotherapy with or without chemotherapy

Exclusion Criteria:

  • Patients who did not give informed consent
  • Patients under prophylaxis for HBV
  • Patients vaccinated for hepatitis B
  • Patients with HBsAg positivity
  • Patients with HIV positivity
  • Patients with current history of alcohol (more than 5 alcohol unit daily) and drug use
  • Patients with other cause of liver disease with known etiology (autoimmune liver disorder and storage liver disease)
  • Patients with current active Hepatitis C virus (HCV-positive)
  • Patients with hepatocellular carcinoma (HCC)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To evaluate the cumulative proportion of patients with OBI who do not develop one seroreversion of HBsAg and/or an increase in serum HBV DNA of at least 1 log above the lower limit of detection of the test in a patient who had previously HBsAg and HBV
Time Frame: 3 weeks after first cycle of therapy and every 3 months until the end of the study

Occult hepatitis B (OBI) detectable in serum HBV DNA, negative antigen test surface hepatitis B (HBsAg) and with positivity to anti-HBc (OBI seropositive).

pOBI: Based on the intermittent detection of HBV DNA, we define pOBI (OBI potential) patients with negative HBV-DNA and positivity to anti-HBc.
3 weeks after first cycle of therapy and every 3 months until the end of the study

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of the association between HBV-specific T-cell response and HBV reactivation
Time Frame: 3 weeks after first cycle of therapy and every 3 months until the end of the study
Evaluation of the association between HBV-specific T-cell response and HBV reactivation
3 weeks after first cycle of therapy and every 3 months until the end of the study
Analysis of the incidence of reactivation of HBV in patients with p-OBI according to tumor characteristics (histology and stage) and type and line of treatment (immunotherapy, combined treatment with chemotherapy + immunotherapy).
Time Frame: 3 weeks after first cycle of therapy and every 3 months until the end of the study
Analysis of the incidence of reactivation of HBV in patients with p-OBI according to tumor
3 weeks after first cycle of therapy and every 3 months until the end of the study
Evaluation of the incidence of reactivation in patients during immunotherapy
Time Frame: 3 weeks after first cycle of therapy and every 3 months until the end of the study
Evaluation of the incidence of reactivation in patients during immunotherapy
3 weeks after first cycle of therapy and every 3 months until the end of the study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione IRCCS Policlinico San Matteo di Pavia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 6, 2022

Primary Completion (Estimated)

May 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

March 26, 2024

First Submitted That Met QC Criteria

April 2, 2024

First Posted (Actual)

April 4, 2024

Study Record Updates

Last Update Posted (Actual)

December 24, 2025

Last Update Submitted That Met QC Criteria

December 18, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OBI&ICI

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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