UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046853 |
|---|---|
| Receipt number | R000053454 |
| Scientific Title | Investigation of hepatitis B virus reactivation after novel molecular targeted therapy with immunostimulatory effect (solid tumors) |
| Date of disclosure of the study information | 2022/02/14 |
| Last modified on | 2024/08/10 13:50:44 |
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Basic information
Public title
Investigation of hepatitis B virus reactivation after novel molecular targeted therapy with immunostimulatory effect (solid tumors)
Acronym
Investigation of Hepatitis B Reactivation by Immune Checkpoint Inhibitors (Solid Tumors)
Scientific Title
Investigation of hepatitis B virus reactivation after novel molecular targeted therapy with immunostimulatory effect (solid tumors)
Scientific Title:Acronym
Investigation of Hepatitis B Reactivation by Immune Checkpoint Inhibitors (Solid Tumors)
Region
| Japan |
Condition
Condition
Solid cancer, Hepatitis B
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To determine the frequency and risk factors for hepatitis B virus reactivation in hepatitis B virus-infected patients who have received chemotherapy, including novel molecular targeted drugs with immunostimulatory effects.
Basic objectives2
Pharmacodynamics
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Frequency of HBV Reactivation during Use of Novel Molecular Targeting Agents with Immunostimulatory Effects
Key secondary outcomes
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
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key 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
Key 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
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Rie |
| Middle name | |
| Last name | Sugimoto |
Organization
National Hospital Organization Kyushu Cancer Center
Division name
Department of Hepato-Biliary-Pancreatology
Zip code
811-1395
Address
3-1-1 Notame Minami-ku Fukuoka city Fukuoka
TEL
0925413231
sugirie5@rr.iij4u.or.jp
Public contact
Name of contact person
| 1st name | Rie |
| Middle name | |
| Last name | Sugimoto |
Organization
National Hospital Organization Kyushu Cancer Center
Division name
Department of Hepato-Biliary-Pancreatology
Zip code
811-1395
Address
3-1-1 Notame Minami-ku Fukuoka city Fukuoka
TEL
0925413231
Homepage URL
sugirie5@rr.iij4u.or.jp
Sponsor or person
Institute
National Institute for Medical Research and Development (AMED)
Institute
Department
Personal name
Funding Source
Organization
National Institute for Medical Research and Development (AMED)
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Hospital Organization Kyushu Cancer Center Ethics Committee
Address
3-1-1 Notame Minami-ku Fukuoka city Fukuoka
Tel
092-541-3231
601-rinri@mail.hosp.go.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
九州がんセンター（福岡県）National Hospital Organization Kyushu Cancer Center(Fukuoka)
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 02 | Month | 14 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
321
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
Paper in preparation and to be resubmitted
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2021 | Year | 12 | Month | 06 | Day |
Date of IRB
| 2022 | Year | 01 | Month | 28 | Day |
Anticipated trial start date
| 2022 | Year | 02 | Month | 14 | Day |
Last follow-up date
| 2022 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
| 2022 | Year | 12 | Month | 30 | Day |
Date trial data considered complete
| 2023 | Year | 03 | Month | 30 | Day |
Date analysis concluded
| 2023 | Year | 05 | Month | 30 | Day |
Other
Other related information
The purpose of this study is to determine the frequency and risk factors of hepatitis B virus reactivation in hepatitis B virus-infected patients who received chemotherapy including a novel molecular target drug with immunostimulating effects.
This study will shed light on risk factors, timing of reactivation, safe use, and cost-benefit surveillance and follow-up timing for novel immunostimulatory molecularly targeted agents.
In this study, novel molecularly targeted drugs with immunostimulatory effects are defined as any of the following five drugs.
PD-1 inhibitors (nivolumab, pembrolizumab), PD-L1 inhibitors (atezolizumab, durvalumab), CTLA-4 inhibitors (ipilimumab)
Management information
Registered date
| 2022 | Year | 02 | Month | 07 | Day |
Last modified on
| 2024 | Year | 08 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053454
