Multicenter cooperative observational study of reactivation of hepatitis B virus caused by everolimus or sorafenib

Multicenter cooperative observational study of reactivation of hepatitis B virus caused by everolimus or sorafenib - HBV surveillance study RADSOR

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000005370

Enrollment

100

Registered

2011-04-10

Start date

2010-08-01

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

Maligant tumor patients with high risk of hepatitis B viral reactivation receiving chemotherapy in which everolimus or sorafenib is contained.

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1)Solid tumor patients receiving chemotherapy in which everolimus and sorafenib is contained 2)Patients with high risk of HBV reactivation: 1.Seropositivity for HBsAg 2.Seronegativity for HBsAg and seropositivity for HBcAb and/or HBsAb 3)Written informed consent

Exclusion criteria

Exclusion criteria: 1) No prior treatment of everolimus and sorafenib 2) During hemodialyis or planning to introuce hemodialyis. 3) Seropositivity to HCVAb 4) Seropositivity for HBsAb only with a history of HBV vaccination 5) Not eligible judged by investigators

Design outcomes

Primary

Measure	Time frame
Incidence rate of HBV reactivation	—

Secondary

Measure	Time frame
Outcome of the patients in whom the HBV reactivation developed Investigation of the background of patients in whom the HBV reactivation developed	—

Countries

Japan

Contacts

Public ContactMasafumi Ikeda, MD.

National Cancer Center Hospital East HBV surveillance data center

masikeda@east.ncc.go.jp04-7133-1111

Outcome results