• Carcino-embryomc antigen (CEA) for patients with CRC. 
• Alpha-fetoprotein (AFP) for patients with HCC. 
7.6.4 Abdomen and pelvis CT or MRI scan. 
To be performed on Day 28 only. If tumor response is noted (Section 1 1.0), 
abdominal scan will be repeated at least 28 days later. 
7.6.5 Special studies: 
• Pharmacokinetics (Section 7.7), to be performed on Day 28 only. 
• Immune responses (Section 7.8) 
• Study Serum Bank (Section 7.9) 
7.7 Pharmacokinetics 
Serum samples will be obtained from the hepatic vein and peripheral veins for 
pharmacokinetic analysis. 
7.7.1 S ampling of hepatic venous blood: 
Selective hepadc vein catheterization will be performed percutaneously via either 
antecubital vein under fluoroscopic guidance prior to ACN53 administration while 
the patient is in the Interventional Radiology Suite. This procedure is part of the 
study evaluations and is not part of standard patient care. Serum samples (10 cc of 
blood) from the hepatic vein will be obtained for pharmacokinetic analysis in 
parallel with sampling of peripheral venous blood pre-infusion and for the first 6 
hours post-infusion. 
7.7.2 Sampling of peripheral venous blood: 
Standard venipuncture of a peripheral vein for 10 cc of blood will be performed 
simultaneously with hepatic vein sampling, and then repeated at the additional times 
indicated below. 
7.7.3 Timing of samples (time following the start of infusion): 
Pre-infusion*; 5*, 15*, and 30* minutes; 1*, 6*, 24, 48, and 72 hours; Days 7, 
14, 21, and 28. (*these time-points will have both hepatic and peripheral venous 
sampling). 
7.7.4 Methodology for ACN53 detection: See Appendix D. 
7.7.5 Methodology for pharmacokinetic analysis: See Appendix D. 
7.8 Immune Responses 
An important component of this study is to evaluate the immunogenicity of ACN53 by 
measuring the serological response of treated patients to the adenoviral vector and to 
recombinant human wild-type p53. 
7.8.1 Serologic responses to be assayed: 
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