Adagloxad Simolenin/OBI-821 in Combination With TACE Therapy in HCC Patients With GALNT14-rs9679162-non-TT Genotype

Inclusion Criteria:

1. Confirmed Diagnosis of HCC
2. Has a Globo-H or SSEA-3 positive tumor as determined by IHC
3. Never received TACE/ chemotherapy/ radiotherapy or targeted agents prior to this study.
4. Patients should be in BCLC clinical stage B (multinodular asymptomatic tumors without extra-hepatic spread or portal vein invasion) with or without unilateral secondary or tertiary branches of portal vein invasion.
5. Child-Pugh functional class A or B.
6. GALNT14- rs9679162 "non TT" genotype
7. At least 1 measurable lesion must be present.
8. ECOG performance status 0 to 1.
9. Age \> 20 years
10. Both men and women enrolled in this trial must use adequate birth control measures during the course of the trial and 4 weeks after last treatment
11. Informed consent must be obtained prior to perform any study procedure.
12. Total bilirubin \< 3.0 mg/dL with no evidence of biliary tract obstruction.
13. Appropriate Serum alanine aminotransferase, aspartate aminotransferase, Absolute neutrophil count, Platelets and Serum creatinine

(16) Antiviral treatment for hepatitis B or C is allowed except for interferon.

Exclusion Criteria:

1. BCLC stage A.
2. Presence of extrahepatic metastasis or main portal vein thrombosis.
3. Child-Pugh score = C.
4. Significant cardiac disease as determined by investigator.
5. Serious bacterial infection requiring systemic antibiotics.
6. Pregnancy
7. Expected non-compliance.
8. Uncontrolled illness including, but not limited to, ongoing infection, congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness.
9. Bleeding esophageal or gastric varices within three months without ligation or sclerosis injection therapy.
10. Subjects with known HIV infection.