Stage III Intrahepatic Cholangiocarcinoma Clinical Trial
Official title:
A Phase I Clinical Trial of Capecitabine and SIR-Spheres® Y-90-Radioembolization in Patients With Advanced Intrahepatic Cholangiocarcinoma
This phase I trial studies the side effects of capecitabine and Y-90 radioembolization in treating patients with bile duct cancer in the liver that has spread to other places in the body and cannot be removed by surgery. Radiation therapy, such as Y-90 radioembolization, injects tiny radioactive Y-90 microspheres into the blood supply next to the liver tumors to kill tumor cells. Capecitabine may make radiation more effective. Giving capecitabine and Y-90 radioembolization may work better in treating patients with bile duct cancer in the liver.
PRIMARY OBJECTIVES:
I. To evaluate the safety and toxicity of capecitabine, to be used in combination with
yttrium Y-90 (yttrium 90) (Y-90) radioembolization (RE), in patients with a diagnosis of
unresectable intrahepatic cholangiocarcinoma (ICC).
SECONDARY OBJECTIVES:
I. To describe the toxicities associated with Y-90 + capecitabine in patients with ICC.
II. To develop a preliminary assessment of efficacy by evaluating liver-specific
progression-free survival (PFS) and overall PFS.
III. To develop a preliminary assessment of efficacy by evaluating response rate according
to Response Evaluation Criteria in Solid Tumors (RECIST)/modified RECIST (mRECIST) and the
Europeans Association for the Study of the Liver (EASL) imaging criteria.
IV. To develop a preliminary assessment of efficacy by evaluating cancer antigen (CA) 19-9
response and its correlation with imaging markers of tumor response.
V. To develop a preliminary assessment of efficacy by evaluating duration of response in the
liver, as measured by the time for target liver lesions to progress according to
RECIST/mRECIST beyond size at study enrollment.
VI. To develop a preliminary assessment of efficacy by evaluating rate of conversion to
surgical resection for subjects who are surgically unresectable at presentation due to size
or location of hepatic lesions (excluding subjects with extrahepatic disease or medically
inoperable at presentation).
VII. To develop a preliminary assessment of efficacy by evaluating overall survival.
OUTLINE:
Patients undergo yttrium Y 90 resin microspheres radioembolization over 60-90 minutes on day
1. Patients receive capecitabine orally (PO) twice daily (BID) on days 1-14.
After completion of study treatment, patients are followed up every 2 months.
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