NCT04891289

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

Recruiting now Phase 2 Last updated 21 April 2026

What this trial tests

Phase 2 trial testing Gemcitabine in Intrahepatic Cholangiocarcinoma in 164 participants. Currently enrolling.

Timeline

7 May 2021

Primary endpoint
1 May 2027

1 May 2027

Quick facts

Lead sponsor	Memorial Sloan Kettering Cancer Center
Phase	Phase 2
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	treatment
Enrollment	164
Start date	7 May 2021
Primary completion	1 May 2027
Estimated completion	1 May 2027
Sites	11 locations across United States, Netherlands

Drugs / interventions tested

• Gemcitabine (gemcitabine) — full drug profile →
• Oxaliplatin (Oxaliplatin) — full drug profile →
• Dexamethasone (dexamethasone) — full drug profile →
• Floxuridine (FUDR)
• Implanted Medical Device

Conditions studied

• Intrahepatic Cholangiocarcinoma — all drugs for Intrahepatic Cholangiocarcinoma →

Sponsor

Memorial Sloan Kettering Cancer Center — full company profile →

Who can join

18 and older, any sex, with Intrahepatic Cholangiocarcinoma. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• assess progression-free survival (PFS)
  Time frame: 2 years
  will be done using RECIST (version 1.1).

Sponsor's own description

This study will compare the safety and effects of HAI floxuridine and dexamethasone combined with the standard chemotherapy drugs gemcitabine and oxaliplatin (GemOx) with those of GemOx alone in people with untreated cholangiocarcinoma that cannot be removed with surgery. The researchers want to find out whether the study treatment works better than the standard chemotherapy to delay progression of disease. For the study treatment to be considered better than the standard treatment, the study treatment should increase the time until progression of disease by an average of 3 months, compared with the usual approach.

Publications & conference data

7 peer-reviewed publications reference this trial (live from Europe PMC):

1. Hepatic Arterial Infusion Pump Chemotherapy for Unresectable Intrahepatic Cholangiocarcinoma: A Systematic Review and Meta-Analysis.
   Holster JJ, El Hassnaoui M, Franssen S, IJzermans JNM, et al · · 2022 · cited 33× · PMID 35294656 · DOI 10.1245/s10434-022-11439-x
2. Current and Emerging Therapeutic Targets for the Treatment of Cholangiocarcinoma: An Updated Review.
   Hadfield MJ, DeCarli K, Bash K, Sun G, et al · · 2023 · cited 12× · PMID 38203714 · DOI 10.3390/ijms25010543
3. Hepatic disease control in patients with intrahepatic cholangiocarcinoma correlates with overall survival.
   Soares KC, Jolissaint JS, McIntyre SM, Seier KP, et al · · 2023 · cited 8× · PMID 37062071 · DOI 10.1002/cam4.5925
4. Advancements in Locoregional Therapies for Unresectable Intrahepatic Cholangiocarcinoma.
   O'Donnell CDJ, Majeed U, Rutenberg MS, Croome KP, et al · · 2025 · cited 6× · PMID 39996882 · DOI 10.3390/curroncol32020082
5. Hepatic Artery Infusion Chemotherapy for Primary and Secondary Malignancies of the Liver: State of the Art and Current High-Level Evidence.
   Kuemmerli C, Hess V, Dutkowski P, Sinz S, et al · · 2024 · cited 3× · PMID 38368862 · DOI 10.1159/000537887
6. Long-term outcomes in patients with advanced intrahepatic cholangiocarcinoma treated with hepatic arterial infusion chemotherapy.
   Cowzer D, Soares K, Walch H, Gönen M, et al · · 2025 · cited 2× · PMID 39331613 · DOI 10.1093/jnci/djae202
7. ASO Author Reflections: Usage of Hepatic Arterial Infusion Pump Chemotherapy for Unresectable Intrahepatic Cholangiocarcinoma.
   Holster JJ, Groot Koerkamp B. · · 2022 · PMID 35266080 · DOI 10.1245/s10434-022-11516-1