UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045557 |
|---|---|
| Receipt number | R000051994 |
| Scientific Title | Multicenter prospective study on prediction of primary resistance to anti PD-1/PD-L1 antibodies by hepatobiliary phase of Gd-EOB-DTPA-enhanced MRI |
| Date of disclosure of the study information | 2021/09/24 |
| Last modified on | 2023/09/26 09:29:59 |
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Basic information
Public title
Multicenter prospective study on prediction of primary resistance to anti PD-1/PD-L1 antibodies by hepatobiliary phase of Gd-EOB-DTPA-enhanced MRI
Acronym
PREDICT study
Scientific Title
Multicenter prospective study on prediction of primary resistance to anti PD-1/PD-L1 antibodies by hepatobiliary phase of Gd-EOB-DTPA-enhanced MRI
Scientific Title:Acronym
PREDICT study
Region
| Japan |
Condition
Condition
Hepatocellular carcinoma
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
Prediction of treatment effect
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
TTP (time to progression) by signal intensity (RER more than 0.9 or RER less than 0.9) of Gd-EOB-DTPA-enhanced MRI
Key secondary outcomes
OS (overall survival) and ORR (objective response rate) by signal intensity (RER more than 0.9 or RER less than 0.9) of Gd-EOB-DTPA-enhanced MRI.
PFS, OS, and ORR by FDG uptake by PETCT.
PFS, OS, ORR by Kupffer phase imaging(iso/hypo/defect) and MFI imaging (fine/vascular/irregular pattern) of CEUS
PFS, OS, and ORR based on the degree of background liver fibrosis (ultrasound elastography, serum markers)
PFS, OS, and ORR by hepatic reserve (Child-Pugh score/grade, ALBI score/grade)
PFS, OS, and ORR by BTR, zinc, and BCAA medication status
PFS, OS, and ORR by patient background (age, gender, hepatitis virus, history of viral therapy, BMI, and renal function)
PFS, OS, and ORR by the ratio of peripheral blood T-cell subsets (CD3+, CD4+, CD8+)
PFS, OS, and ORR by Relative Dose Intensity (RDI).
PFS, OS, and ORR based on the profile of T cells of peripheral blood at 1-2 weeks after initiation of the therapy.
AEs (Adverse Events) of immune checkpoint inhibitors
Changes in ALBI score and Child-Pugh score
In patients who underwent liver biopsy, analysis of the tumor microenvironment (comprehensive genetic analysis including TMB and special immunostaining) will be performed to investigate factors associated with the effect of immune checkpoint inhibitors.
Metagenomic analysis of the intestinal microbiota in feces using next-generation sequencing of the 16SrRNA gene will be performed to examine the relationship with the therapeutic effect.
We will examine the relationship between genetic mutations and treatment effects on cell free DNA (cfDNA) obtained by liquid biopsy before treatment and during treatment exacerbation.
Correlation analysis of the RER measured by two radiologists will be performed.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Age 18 years or older (regardless of gender)
2) Patients diagnosed with typical hepatocellular carcinoma by histological/cytological diagnosis or imaging diagnosis such as abdominal ultrasonography or dynamic CT (MRI) according to AASLD criteria.
3) ECOG PS of 0 or 1
4) Patients who are scheduled to receive, are receiving, or have discontinued treatment with a regimen containing anti-PD-1/PD-L1 antibody for unresectable advanced liver cancer between January 1, 2020 and December 31, 2025.
5) Patients with untreated intrahepatic lesions evaluable by Gd-EOB-DTPA-enhanced MRI taken at least 3 months prior to the initiation of anti-PD-1/PD-L1 antibody
6) Child-Pugh class A
7) Patients who have undergone upper gastrointestinal endoscopy at least six months prior to the start of treatment.
8) Patients who can be expected to have a prognosis of at least 3 months
Key exclusion criteria
1) Patients with malignant tumor of other organ that is difficult disease control
2) Patients with esophagogastric varices at high risk of rupture
3) Patients who are pregnant or who wish to have a baby during treatment
4) Refusal to give informed consent
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Masatoshi |
| Middle name | |
| Last name | Kudo |
Organization
Kindai University Faculty of Medicine
Division name
Department of Gastroenterology and Hepatology
Zip code
589-8511
Address
377-2 Ohno-higashi Osaka-Sayama, Japan
TEL
+81-72-366-0221
m-kudo@med.kindai.ac.jp
Public contact
Name of contact person
| 1st name | Tomoko |
| Middle name | |
| Last name | Aoki |
Organization
Kindai University Faculty of Medicine
Division name
Department of Gastroenterology and Hepatology
Zip code
589-8511
Address
377-2 Ohno-higashi Osaka-Sayama, Japan
TEL
+81-72-366-0221
Homepage URL
t.aoki1918@gmail.com
Sponsor or person
Institute
Kindai University
Institute
Department
Personal name
Funding Source
Organization
Kindai University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kinki University Ethics Committee
Address
377-2 Ohno-higashi Osaka-Sayama, Japan
Tel
+81-72-366-0221
zizen@med.kindai.ac.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
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 09 | Month | 24 | 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
165
Results
Results date posted
Results Delayed
Results Delay Reason
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
| 2020 | Year | 10 | Month | 12 | Day |
Date of IRB
| 2021 | Year | 03 | Month | 04 | Day |
Anticipated trial start date
| 2021 | Year | 09 | Month | 24 | Day |
Last follow-up date
| 2023 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
| 2023 | Year | 09 | Month | 09 | Day |
Date trial data considered complete
| 2023 | Year | 09 | Month | 09 | Day |
Date analysis concluded
| 2023 | Year | 12 | Month | 31 | Day |
Other
Other related information
observational study
Management information
Registered date
| 2021 | Year | 09 | Month | 24 | Day |
Last modified on
| 2023 | Year | 09 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051994
