Hepatic Arterial Infusion Chemotherapy(HAIC) for Hepatoma After Resection

Inclusion Criteria:

• 18 years and older

• Informed consent Confirmation of diagnosis of HCC: For subjects undergoing surgicalresection histological confirmation is mandatory (a post surgery pathology report isrequired for both histological confirmation and risk stratification).

• After qualifying at the time of scanning, by independent radiology review diagnosed CR (no residual tumor deposit radical therapy Assess their level of risk of diseaserecurrence by tumor characteristics as moderate or high risk

• Subjects who have undergone surgical resection for treatment of HCC with curativeintent within 4 months from staging to potentially curative treatment.

• At least 3 weeks (21 days) but not more than 7 weeks (49 days), from resection course,to CT/MRI scan date. A timeframe of 4 weeks after surgical resection is recommended.

• Male or female subjects ≥ 18 years of age Confirmation of complete response(CR)- (absence of residual tumor after curative treatment), on the eligibility scan byindependent radiological review.

• For subjects undergoing surgical resection pathology proven complete removal of tumor.Intermediate or High Risk of recurrence as assessed by tumor characteristics.

• Child-Pugh score 5 -7 points. A Child-Pugh score of 7 points is allowed only in theabsence of ascites.

• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0.

• Adequate bone marrow, liver and renal function as assessed by central lab by means ofthe following laboratory requirements from samples within 14 days prior torandomization: Alpha fetoprotein ≤ 400 ng/mL

• Women of childbearing potential must have a negative serum pregnancy test performedwithin 14 days prior to the start of treatment (assessed centrally).

Exclusion Criteria:

• Recurrent HCC Child-Pugh score 7 points with presence of ascites.

• The following tumor characteristics: Low risk of recurrence after curative treatmentdefined as any of the following: for local ablation patients: single lesions ≤ 2 cmfor surgical resection patients: single lesions ≤ 2 cm without microscopic vascularinvasion, without tumor satellites and histologically well differentiated. ≥ 3 lesionsor 2-3 lesions of which any are ≥ 3 cm in size (largest diameter, unidimensionalmeasurement) prior curative treatment (surgical resection or local ablation) singlelesion ≥ 5 cm (largest diameter, unidimensional measurement) in size prior localablation.

• Macrovascular invasion Extrahepatic spread (including regional lymph nodes andinvasion into adjacent structures)

• History of cardiovascular disease:

• History of HIV infection Active clinically serious infections (≥ grade 2 NCI-CTCAEversion 3.0)

• Subjects with seizure disorder requiring medication (such as steroids oranti-epileptics)

• History of organ allograft Subjects with evidence or history of bleeding diathesis

• Subjects undergoing renal dialysis

• Previous or concurrent cancer that is distinct in primary site or histology from thecancer being evaluated in this study EXCEPT cervical carcinoma in situ, treated basalcell carcinoma, superficial bladder tumors [Ta, Tis & T1] or any cancer curativelytreated ≥ 3 years prior to study entry as defined by the signing of informed consent.

• Uncontrolled ascites (defined as not easily controlled with diuretic treatment)

• Encephalopathy History of GI bleeding within 30 days of randomization.

• Subjects with a history of esophageal varices bleeding which has not been followed byeffective therapy and/or treatment to prevent bleeding recurrence.

• Prior anti cancer therapy for treatment of HCC (including sorafenib or any othermolecular therapy) is excluded.

• Major surgery within 4 weeks of start of study as defined by the signing of informedconsent, except for surgical resection or local ablation of HCC.

• Autologous bone marrow transplant or stem cell rescue within 4 months of study entryas defined by the signing of informed consent.

• Use of biologic response modifiers, such as colony stimulating factor(G-CSF), within 3week of study entry, as defined by the signing of informed consent.

• Investigational drug therapy outside of this trial during or within 4 weeks of studyentry, as defined by the signing of informed consent.

• Pregnant or breast-feeding subjects.

• Substance abuse, medical, psychological or social conditions that may interfere withthe subject's participation in the study or evaluation of the study results

• Known or suspected allergy to contrast media for angiography.

• Any condition that is unstable or could jeopardize the safety of the subject and theircompliance in the study

• This applies to subjects with severe obstruction of the upper GI tract that requiregavage.