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A Randomized Phase II Study of Systemic Chemotherapy with or without HAI FUDR/Dexamethasone in Patients with Unresectable Intrahepatic Cholangiocarcinoma

Status
Not yet recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-518065-10-00
Acronym
20-348
Enrollment
60
Registered
2024-11-08
Start date
Unknown
Completion date
Unknown
Last updated
2025-09-30

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

Conditions

Unresectable intrahepatic cholangiocarcinoma

Brief summary

Progression-free survival

Detailed description

1. Compare the overall survival in first-line HAI FUDR/Dex in combination with GemOx versus systemic GemOx only., 2. Estimate the overall response rate (CR+PR) between treatment groups., 3. Estimate the time to first recurrence patterns between treatment groups., 4. Describe the toxicity rates separately for each treatment groups., Define the mutational pattern of IHC and determine the extent to which genomic features and intratumoral heterogeneity correlate with treatment response and survival.

Interventions

DRUG-

Sponsors

Memorial Sloan Kettering Cancer Center
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Secondary

MeasureTime frame
1. Compare the overall survival in first-line HAI FUDR/Dex in combination with GemOx versus systemic GemOx only., 2. Estimate the overall response rate (CR+PR) between treatment groups., 3. Estimate the time to first recurrence patterns between treatment groups., 4. Describe the toxicity rates separately for each treatment groups., Define the mutational pattern of IHC and determine the extent to which genomic features and intratumoral heterogeneity correlate with treatment response and survival.

Primary

MeasureTime frame
Progression-free survival

Countries

Netherlands

Outcome results

None listed

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