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Gemcitabine and Oxaliplatin Chemotherapy With or Without a Floxuridine and Dexamethasone Pump in People With Cholangiocarcinoma That Cannot Be Removed With Surgery

NCT04891289 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 164

Last updated 2026-04-22

No results posted yet for this study

Summary

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.

Conditions

  • Intrahepatic Cholangiocarcinoma

Interventions

DRUG

Gemcitabine

See arm for details.

DRUG

Oxaliplatin

See arm for details.

DRUG

Dexamethasone

See arm for details.

DRUG

Floxuridine (FUDR)

See arm for details.

DEVICE

Implanted Medical Device

Implanted hepatic arterial infusion pump by surgical oncology, to deliver HAI therapy

Sponsors & Collaborators

Principal Investigators

  • Andrea Cercek, MD · Memorial Sloan Kettering Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-07
Primary Completion
2027-05-31
Completion
2027-05-31
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States
  • Netherlands

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04891289 on ClinicalTrials.gov