Pharmacokinetics of Doxorubicin in cTACE of Liver Cancer

Patients with primary and secondary liver cancer may participate in this study. The purpose
is to perform an analysis of the effects of doxorubicin and its metabolite doxorubicinol on
the body (doxorubicin pharmacokinetics ) after conventional transarterial chemoembolization
(cTACE). A pharmacokinetics profile (PK profile) will be constructed and will include peak of
plasma concentration (Cmax), time of maximum concentration (TMax), and area under the
concentration curve (AUC). This composite measure will be used to compare patients in cTACE
lobar administration and cTACE superselective administration. In addition, the PK profile
will be correlated with toxicity, tumor burden, body surface area, and gender. Feasibility
and safety will also be assessed.

Inclusion Criteria:

1. Age ≥ 18 years.

2. Histologically, cytologically, or radiologically confirmed liver dominant or liver
only malignancy.

3. Preserved liver function (Child-Pugh A-B class) without significant liver
decompensation.

4. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 at study entry.

5. Measurable or evaluable disease that will be directly treated with intrahepatic
therapy (as defined by Response Evaluation Criteria in Solid Tumors [RECIST] 1.1).

6. Suitable for TACE based on blood parameters such as platelet count, bilirubin, and
international normalized ratio.

7. May be enrolled with a history of prior liver directed intra-arterial therapy if
intra-arterial therapy to the target lesion occured > 1 year prior to enrollment date.
Intra-arterial therapy to different targets within 1 year prior to enrollment date
will not exclude subjects.

Exclusion Criteria:

1. Serum total bilirubin > 3.0 mg/dL

2. Creatinine > 2.0 mg/dL

3. Platelets < 50000/µL

4. Complete portal vein thrombosis with reversal of flow

5. Ascites (trace ascites on imaging is acceptable)