Investigation of hepatitis B virus reactivation after novel molecular targeted therapy with immunostimulatory effect (solid tumors)

Investigation of hepatitis B virus reactivation after novel molecular targeted therapy with immunostimulatory effect (solid tumors) - Investigation of Hepatitis B Reactivation by Immune Checkpoint Inhibitors (Solid Tumors)

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000046853

Enrollment

200

Registered

2022-02-14

Start date

2022-02-14

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Solid cancer, Hepatitis B

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Eligibility Criteria for Cohort 1 1) HBsAg-positive patients (with or without HBV reactivation) who started chemotherapy including a novel immunostimulatory molecular target (one of nivolumab, pembrolizumab, atezolizumab, durvalumab, or ipilimumab) at a collaborating institution between January 2014 and December 2020 2) HBV DNA has been measured at least once after chemotherapy 3) Follow-up for at least 6 months after initiation of chemotherapy Eligibility Criteria for Cohort 2 (1) Patients with previous HBV infection who started chemotherapy including a new molecular target drug with immunostimulatory activity (nivolumab, pembrolizumab, atezolizumab, durvalumab, or ipilimumab) at the collaborating institutions between January 2014 and December 2020 (HBc antibody Positive for HBc antibody or positive for HBs antibody. However, HBc- or HBs-antigen-negative patients who are positive for HBc- or HBs-antibody alone and have a clear history of HB vaccination will not be considered as previously infected with HBV.) (2) Patients with HBV reactivation (increase in HBV DNA detection sensitivity or HBs antigen positivity) after chemotherapy (Common to Cohort 1 and Cohort 2) 1) Have indicated their intention not to participate in this study 2) Have been judged ineligible for this study by the principal investigator at each institution

Exclusion criteria

Exclusion criteria: (Common to Cohort 1 and Cohort 2) 1) Have indicated their intention not to participate in this study 2) Have been judged ineligible for this study by the principal investigator at each institution

Design outcomes

Primary

Measure	Time frame
Frequency of HBV Reactivation during Use of Novel Molecular Targeting Agents with Immunostimulatory Effects	—

Secondary

Measure	Time frame
Changes in the amount of HBV during the use of new molecular target drugs with immunostimulating effects, primary disease, whether or not a nucleic acid analog was administered, details of chemotherapy, whether or not HCV was involved, the titer of HBS antigen, differences in the frequency of reactivation according to changes in HBV-related markers HBV reactivation frequency, presence or absence of HBV reactivation-related liver injury, presence or absence of immune-related liver injury requiring systemic steroid therapy, presence or absence of HBV reactivation-related fulminant liver injury HBV reactivation-related fulminant hepatitis incidence rate, non-compensated cirrhosis incidence rate, hepatocellular carcinoma incidence rate, HBV reactivation-related hepatotoxicity incidence rate after discontinuation of nucleoside analogues, and death	—

Measure

Time frame

Changes in the amount of HBV during the use of new molecular target drugs with immunostimulating effects, primary disease, whether or not a nucleic acid analog was administered, details of chemotherapy, whether or not HCV was involved, the titer of HBS antigen, differences in the frequency of reactivation according to changes in HBV-related markers HBV reactivation frequency, presence or absence of HBV reactivation-related liver injury, presence or absence of immune-related liver injury requiring systemic steroid therapy, presence or absence of HBV reactivation-related fulminant liver injury HBV reactivation-related fulminant hepatitis incidence rate, non-compensated cirrhosis incidence rate, hepatocellular carcinoma incidence rate, HBV reactivation-related hepatotoxicity incidence rate after discontinuation of nucleoside analogues, and death

—

Countries

Japan

Contacts

Public ContactRie Sugimoto

National Hospital Organization Kyushu Cancer Center Department of Hepato-Biliary-Pancreatology

sugirie5@rr.iij4u.or.jp0925413231

Outcome results