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

N/AActive Not RecruitingNCT06347588

Fondazione IRCCS Policlinico San Matteo di Pavia60 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

Conditions

Occult Hepatitis B Infection in Cancer Patients

Interventions

Observational: Blood sample of HVB-specific Elispot assay, HBSAg, HBV-DNAOTHER

Blood sample at baseline, week 4, month 3, 6, 9,12.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Locations (1)

Irccs San Matteo Pavia

Pavia, PV, Italy

Outcomes

Primary Outcomes

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

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.

Time frame: 3 weeks after first cycle of therapy and every 3 months until the end of the study

Secondary Outcomes

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 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

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).

Analysis of the incidence of reactivation of HBV in patients with p-OBI according to tumor

Time frame: 3 weeks after first cycle of therapy and every 3 months until the end of the study

Data from ClinicalTrials.gov

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