Precision Medicine in patients with unresectable CholAngiocarcinoma; RadioEmbolization and combined biological therapy (PM-CARE). Single arm, multicenter phase II study investigating the efficacy and safety of a novel therapeutic scheme in patients with unresectable CholAngiocarcinoma; RadioEmbolization in combination with CisGem and Durvalumab (MEDI4736)

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-516498-57-00

Acronym

PM-CARE

Enrollment

Registered

2024-11-18

Start date

2024-04-30

Completion date

Unknown

Last updated

2025-10-22

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

Conditions

liver predominant intrahepatic cholangiocarcinoma

Brief summary

Efficay:Overall response rate (ORR) according to mRECIST criteria on imaging at 6 months, Safety:Evaluate adverse events, laboratory findings, vital signs and other diagnostic evaluation alterations

Detailed description

mRECIST criteria on imaging time points, Overall response rate according to mRECIST and RECIST 1.1 criteria at three months (interim analysis) Overall response rate according to RECIST 1.1 criteria at six months, Serial blood sampling; cytokine profiling Biopsy prior to and following treatment, Serial imaging at given time points, Tissue and blood samples, Associate ORR to mRECIST and RECIST at 6 months from the start of treatment: OS right censored to end of study

Interventions

DRUGIMFINZI 50 mg/mL concentrate for solution for infusion.

DRUGCisplatino Accord Healthcare Italia 1 mg/ml concentrato per soluzione per infusione

DRUGGemcitabina Accord 100 mg/ml concentrato per soluzione per infusione.

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Efficay:Overall response rate (ORR) according to mRECIST criteria on imaging at 6 months, Safety:Evaluate adverse events, laboratory findings, vital signs and other diagnostic evaluation alterations	—

Secondary

Measure	Time frame
mRECIST criteria on imaging time points, Overall response rate according to mRECIST and RECIST 1.1 criteria at three months (interim analysis) Overall response rate according to RECIST 1.1 criteria at six months, Serial blood sampling; cytokine profiling Biopsy prior to and following treatment, Serial imaging at given time points, Tissue and blood samples, Associate ORR to mRECIST and RECIST at 6 months from the start of treatment: OS right censored to end of study	—

Measure

Time frame

—

Countries

Italy

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026