A Study of Cisplatin or Carboplatin With Gemcitabine Versus Gemcitabine Alone as Adjuvant Therapy in Patients With Resected or Ablation Intra-Hepatic Cholangiocarcinoma

Phase III, multicenter, open label, randomized study of Cisplatin or Carboplatin with
Gemcitabine versus Gemcitabine alone as adjuvant therapy in patients with resected or ablated
intra-hepatic cholangiocarcinoma. Subjects will be randomized in a 1:1 fashion to Cisplatin
or Carboplatin with Gemcitabine versus Gemcitabine alone.

Inclusion Criteria:

- At least 18 years of age, of any race or sex who are eligible to sign written consent
and have undergone prior resection of histological evidence of intrahepatic
cholangiocarcinoma

- Hematologic function: ANC ≥ 1.5 x 10 /L, platelets ≥ 75 x 10 /L, and hemoglobin > 9
g/dL

- Adequate liver function as measured by: total bilirubin ≤ 2.0 mg/dl, AST and ALT ≤ 5
ULN, albumin ≥ 2.5 g/dl

- Adequate renal function as measured by: creatinine ≤ 2.9 mg/dl, > 50 ml/min calculated
by the C-G equation

- Non-pregnant women of child bearing potential and fertile men are required to use
effective contraception (negative pregnancy test for women of child-bearing age)

- ECOG status ≤ 1 at screening

Exclusion Criteria:

- Subjects will be eligible for the study if they meet all inclusion criteria