Hepatocellular Carcinoma

TACE against HCC is the standard of care for BCLC stage B patients. In this exploratory study, the investigators assess the efficacy of TACE with or without adagloxad simolenin/OBI-821 treatment in GALNT14 "non-TT" HCC population.

Adagloxad simolenin (OBI-822)/OBI-821

Adagloxad simolenin (OBI-822)
OBI-821

Freeze-dried dosage form
Freeze-dried dosage form

37.5 μg
150 μg

time-to-ITTVP [ Time Frame: From enrollment till 36 months of follow-up. ]
time-to-intrahepatic total tumor volume progression

Inclusion Criteria:

Confirmed Diagnosis of HCC
Has a Globo-H or SSEA-3 positive tumor as determined by IHC
Never received TACE/ chemotherapy/ radiotherapy or targeted agents prior to this study.
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.
Child-Pugh functional class A or B.
GALNT14- rs9679162 "non TT" genotype
At least 1 measurable lesion must be present.
ECOG performance status 0 to 1.
Age > 20 years
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
Informed consent must be obtained prior to perform any study procedure.
Total bilirubin < 3.0 mg/dL with no evidence of biliary tract obstruction.
Appropriate Serum alanine aminotransferase, aspartate aminotransferase, Absolute neutrophil count, Platelets and Serum creatinine

Exclusion Criteria:

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