This trial studies the side effects and best dose of Yttrium Y 90-transarterial radioembolization (TARE) when given together with gemcitabine hydrochloride and cisplatin in treating patients with liver cancer that cannot be removed by surgery. Transarterial radioembolization uses radioactive drugs, such as Yttrium Y 90 resin microspheres, to kill tumor cells by carrying radiation directly to tumor cells without harming normal cells. Drugs used in chemotherapy, such as gemcitabine hydrochloride and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving Yttrium Y 90-transarterial radioembolization together with gemcitabine hydrochloride and cisplatin may kill more tumor cells.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT02512692.
PRIMARY OBJECTIVE:
I. To determine the safety and maximum tolerated dose (MTD) of 90Y (Yttrium Y 90 resin microspheres) TARE in combination with gemcitabine (gemcitabine hydrochloride) and cisplatin in patients with unresectable intrahepatic cholangiocarcinoma.
SECONDARY OBJECTIVES:
I. To determine progression free survival.
II. To determine if changes in apparent diffusion coefficient (ADC) on magnetic resonance (MR) predict overall survival in patients treated with chemotherapy and 90Y TARE.
III. To determine the response to the combination of chemotherapy and 90Y TARE based on molecular subtype of intrahepatic cholangiocarcinoma (ICC).
IV. To determine if gamma-glutamyl transferase (GGT) level at diagnosis and after treatment is predictive of overall survival.
OUTLINE: This is a dose-escalation study of Yttrium Y 90 resin microspheres transarterial radioembolization and gemcitabine hydrochloride.
Patients receive Yttrium Y 90 resin microspheres transarterial radioembolization intra-arterially on days 3 or 4 of cycle 1 only. Patients also receive cisplatin intravenously (IV) over 1-2 hours and gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 every 21 days for up to 8 cycles in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 3 months for up to 2 years, every 6 months for 4 years and then periodically thereafter.
Trial PhaseNo phase specified
Trial Typetreatment
Lead OrganizationMedical University of South Carolina
Principal InvestigatorSamuel Lewis Cooper