Multicenter prospective study on prediction of primary resistance to anti PD-1/PD-L1 antibodies by hepatobiliary phase of Gd-EOB-DTPA-enhanced MRI

Multicenter prospective study on prediction of primary resistance to anti PD-1/PD-L1 antibodies by hepatobiliary phase of Gd-EOB-DTPA-enhanced MRI - PREDICT study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000045557

Enrollment

200

Registered

2021-09-24

Start date

2021-09-24

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

Hepatocellular carcinoma

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
TTP (time to progression) by signal intensity (RER more than 0.9 or RER less than 0.9) of Gd-EOB-DTPA-enhanced MRI	—

Secondary

Measure	Time frame
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.	—

Measure

Time frame

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.

—

Countries

Japan

Contacts

Public ContactTomoko Aoki

Kindai University Faculty of Medicine Department of Gastroenterology and Hepatology

t.aoki1918@gmail.com+81-72-366-0221

Outcome results