90Y Transarterial Radioembolization (TARE) Plus Gemcitabine and Cisplatin in Unresectable Intrahepatic Cholangiocarcinoma

Inclusion Criteria:

- Histologic Documentation: Core needle biopsy or surgical specimen that confirms
intrahepatic cholangiocarcinoma (ICC). Patients must be determined to be unresectable
by a multidisciplinary team that includes a hepatobiliary surgeon.

- No prior liver radiation therapy or immunotherapy for cholangiocarcinoma.

- Only previous single agent chemotherapy for ICC allowed.

- Patient may have prior liver resection.

- Age > 18 years of age.

- Eastern Cooperative Oncology Group (ECOG) performance status < 2 (see Appendix E)

- Child's Pugh score of A (see Appendix F)

- Life expectancy of greater than 4 months

- Normal organ and marrow function as outlined in the protocol.

- Willingness to use effective contraceptive methods during the study. Patient may
participate in the female (or female partner of male subject), either is not of
childbearing potential (defined as postmenopausal for > 1 year or surgically sterile)
or is practicing two forms of contraception. Sexually active male participants must
agree to use a physical barrier method (male latex rubber condom with or without
spermicide).

- Patients with well controlled HIV infection are eligible if their CD4 count is >499/cu
mm and viral load is < 50 copies/ml.

- Pre-certification for the 90Y TARE should be performed prior to enrollment on this
study.

- All patients must be informed of the investigational nature of this study and must
have the ability to understand and the willingness to sign a written informed consent
document.

Exclusion Criteria:

- Patients who have had major surgery within 4 weeks prior to entering the study or
those who have not recovered from complications from a surgery more than 4 weeks
earlier.

- Patients may not be receiving any other investigational agents.

- Patients must not have any grade III/IV cardiac disease as defined by the New York
Heart Association (NYHA) Criteria

- Patients must NOT have liver disease such as cirrhosis or sever hepatic impairment as
defined by Child-Pugh Class B or C

- Pregnant women are excluded from this study.