7.4.1 Careful inspection of the liver and adjacent viscera, with observations included in a 
detailed operadve report. 
7.4.2 Placement of the hepatic artery infusion pump will be performed in the usual 
fashion. Pump placement will precede any study-related procedure such as biopsy. 
7.4.3 Biopsy of normal liver. 
A sample of approximately 1 gram of grossly normal liver which appears to the 
operator to be at least 2 cm from gross tumor will be obtained. Hemostasis will be 
accomplished using electrocautery. A portion of this biopsy will be sent to the 
pathology service for pathologic examination. The remainder of the biopsy will be 
cryopreserved in liquid nitrogen, paraformaldehyde, and OCT and submitted to the 
Study Tissue Bank for biological efficacy studies (Section 7.9). 
7.4.4 Biopsy of malignant liver tumor(s). 
For superficial liver tumors, a sample of approximately 1 gram of tumor will be 
obtained by wedge biopsy. For deeper liver tumors, a sample of approximately 250 
milligrams of tumor wUl be obtained by Tru-cut needle biopsy. Hemostasis will be 
accomplished using electrocautery. A portion of this biopsy will be sent to the 
pathology service for pathologic examination. The remainder of the biopsy will be 
cryopreserved in liquid nitrogen, paraformaldehyde, and OCT and submitted to the 
Study Tissue Bank for biological efficacy studies (Section 7.9). 
7.5 Fine Needle Aspiration 
Patients who do not undergo laparotomy will receive percutaneous fine needle aspiration of 
the liver tumor and normal liver as guided by ultrasound or computed tomography. These 
patients will have the following additional evaluations: 
7.5.1 Ultrasound or CT scan with formal report. 
7.5.2 The fine needle aspirates will be submitted for cytopathologic examination, and also 
cryopreserved and submitted to the Study Tissue Bank for biological efficacy 
studies (Section 7.9). 
7.6 Post-Study and Follow-Up Evaluations 
Patients will be considered to be actively on study from the time of Study Admission until 
the Post-Study Evaluations on Day 28. Patients will be considered associated with the 
study after the Post-Study Evaluations and will undergo regular Follow-Up Evaluations for 
the duration of their lifetime. 
The following evaluations will be performed on an outpatient basis on Day 28 (Post-Study 
Evaluations), then every 2 months for one year, then yearly (Follow-Up Evaluations), 
except as noted: 
7.6.1 Complete history, physical examination, and toxicity evaluation, as in 7.2.1. 
7.6.2 Laboratory tests, as in 7.2.2. 
7.6.3 Tumor markers: 
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