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Report for Clinical Trial NCT03608878

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

Randomized, Controlled, Open Label, Clinical Trial for Adagloxad Simolenin/OBI-821 in Combination With TACE Therapy in Hepatocellular Carcinoma Patients With GALNT14-rs9679162-non-TT Genotype

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.

NCT03608878 Hepatocellular Carcinoma
MeSH:Carcinoma Carcinoma, Hepatocellular
HPO:Carcinoma Hepatocellular carcinoma

2 Interventions

Name: adagloxad simolenin/OBI-821

Description: Adagloxad simolenin (OBI-822) is a glyco-conjugated protein comprised of a carbohydrate tumor antigen. Globo H allyl glycoside is covalently linked to a carrier protein KLH, presented in a dominant trimer form with molecular weight between 1200-1395 kDa., to form Adagloxad simolenin (OBI-822) (Globo H-KLH) OBI-821 is a saponin based adjuvant structurally similar to descriptions found in the literature for another adjuvant, QS-21. Adagloxad simolenin will be mixed with OBI-821 before administration.
Type: Biological
Group Labels: 1

adagloxad simolenin arm

Name: TACE

Description: Transarterial chemoembolization
Type: Procedure
Group Labels: 2

TACE alone arm adagloxad simolenin arm

Primary Outcomes

Description: time-to-intrahepatic total tumor volume progression

Measure: time-to-ITTVP

Time: From enrollment till 36 months of follow-up.

Purpose: Treatment

Allocation: Randomized

Parallel Assignment

There is one SNP


1 rs9679162

5. Child-Pugh functional class A or B. 6. GALNT14- rs9679162 "non TT" genotype 7.

HPO Nodes