Clinical Trial for GALNT14 Genotype - Guided, Sorafenib in Combination With TACE in Hepatocellular Carcinoma
Hepatocellular Carcinoma

About this trial
This is an interventional treatment trial for Hepatocellular Carcinoma focused on measuring SNPs
Eligibility Criteria
Inclusion Criteria:
Confirmed Diagnosis of HCC:
Cirrhotic subjects: Clinical diagnosis by AASLD criteria HCC can be defined in cirrhotic subjects by one imaging technique (CT scan, MRI, or second generation contrast ultrasound) showing a nodule larger than 2cm with contrast uptake in the arterial phase and washout in venous or late phases, or two imaging techniques showing this radiological behaviour for nodules of 1-2cm in diameter Cytohistological confirmation is required for subjects who do not fulfill these eligibility criteria
Non-cirrhotic subjects:
For subjects without cirrhosis, histological confirmation is mandatory Documentation of original biopsy for diagnosis is acceptable
- Never received TACE/ chemotherapy/ radiotherapy or targeted agents prior to this study.
- Patients should be either 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. Main portal vein invasion or extra-hepatic spread is not allowed.
- Child-Pugh functional class A or B.
- Measurable disease using mRECIST criteria. At least 1 measurable lesion must be present.
- ECOG performance status 0 to 1.
- Age > 18 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 the completion of trial
- Informed consent must be obtained prior to study initiation.
- Total bilirubin < 3.0 mg/dL with no evidence of biliary tract obstruction.
- Serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) < 5 × upper limit of normal.
- Absolute neutrophil count > 1000/mm3; Platelets ≧ 60x109/L.
- Serum creatinine < 2 x ULN.
- Antiviral treatment for hepatitis B or C is allowed except for interferon.
Exclusion Criteria:
- BCLC stage A.
- Presence of extrahepatic metastasis.
- Child-Pugh score =C
- Significant cardiac disease.
- Serious bacteria infection requiring systemic antibiotics.
- Pregnancy
- Expected non-compliance.
- Uncontrolled illness including, but not limited to, ongoing infection, congestive hear failure, unstable angina pectoris, cardiac arryhythmia, or psychiatric illness.
- Bleeding esophageal or gastric varices within three months without ligation or sclerosis injection therapy.
- Subjects with known HIV infection.
- ECOG status > or = 2
Sites / Locations
- Chang Gung Memorial Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Active Comparator
Active Comparator
Experimental
GALNT14 TT
GALNT14 non-TT TACE alone
GALNT14 non-TT TACE plus sorafenib
Patients will be treated by Transcatheter arterial chemoembolization every 12 ± 2 weeks dependent on CT evaluation. Before each TACE, dynamic CT will be performed for pre-treatment evaluation. When no viable tumor is seen on CT, TACE is to be discontinued.
Patients will be treated by Transcatheter arterial chemoembolization every 12 ± 2 weeks dependent on CT evaluation. Before each TACE, dynamic CT will be performed for pre-treatment evaluation. When no viable tumor is seen on CT, TACE is to be discontinued.
Patients will be treated by Transcatheter arterial chemoembolization every 12 ± 2 weeks dependent on CT evaluation, plus sorafenib adjuvant therapy. Before each TACE, dynamic CT will be performed for pre-treatment evaluation. When no viable tumor is seen on CT, TACE is to be discontinued. patients will receive sorafenib 400 mg/d between each TACE. Patient will start receiving Sorafenib on Day 4 (up to Day 7) after 1st TACE (Day 1) and will interrupt after evening dose 4 days before each next TACE and re-start Sorafenib on Day 4 (up to Day 7) after each TACE cycle.Additional sorafenib treatment is optional and will be judged by investigator in the subject's best medical interest.