Comparative, Prospective, Open-labeled, Randomized Phase II Study of Cisplatin/Gemcitabine in Combination With Irinotecan-loaded LC Bead Versus Cisplatin/Gemcitabine Alone in the Treatment of Patients With Unresectable Intrahepatic Cholangiocarcinoma

Inclusion Criteria

Inclusion:

- Patients over 18 years of age, of any race or sex, who have histologic and radiologic
evidence of intrahepatic cholangiocarcinoma, who have been deemed unresectable by an
experienced hepatic surgeon, and who are able to give informed consent, will be
eligible

- Patients with at least one measurable liver tumor, with size > 1cm (modified RECIST
criteria)

- Patients with liver-dominant disease defined as ≥80% tumor burden confined to the
liver

- Non-pregnant with an acceptable contraception in premenopausal women.

- Hematologic function: ANC ≥ 1.5 x 109/L, platelets ≥ 75 x109/L, INR ≤1.3 (patients on
therapeutic anticoagulants are not eligible if they can not stop there
anti-coagulation prior to DEBIRI and meet INR criteria)

- Adequate liver function as measured by: Total bilirubin ≤ 2.0 mg/dl,

- Adequate renal function (creatinine ≤ 2.3 mg/dl)

- Women of child bearing potential and fertile men are required to use effective
contraception (negative serum βHCG for women of child-bearing age)

- Signed, written informed consent

- Less than 70% of liver parenchymal tumor replacement

Exclusion:

- Patient eligible for curative treatment (i.e. resection or tumor ablation).

- Active bacterial, viral or fungal infection within 72 hours of study entry

- Women who are pregnant or breast feeding

- ECOG Performance Status score of >3

- Life expectancy of < 3 months

- Allergy to contrast media that cannot be managed with standard care (e.g. steroids),
making magnetic resonance imaging (MRI) or computed tomography (CT) contraindicated

- Presence of another malignancy with the exception of cervical carcinoma in situ and
stage I basal or squamous cell carcinoma of the skin.

- Any contraindication for hepatic embolization procedures:

- Large shunt as determined by the investigator (pretesting with TcMMA not required)

- Severe atheromatosis vascular disease that precludes arterial cannulization

- Hepatofugal blood flow

- Main portal vein occlusion (e.g. thrombus or tumor)

- Other significant medical or surgical condition, or any medication or treatment, that
would place the patient at undue risk and that would preclude the safe use of
chemoembolization or would interfere with study participation

- Patients with prior contraindications for the use of irinotecan, gemcitabine, or
cisplatin

- Patients who have received prior systemic therapy with either irinotecan,
gemcitabine, or cisplatin