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

Summary

Transcatheter arterial chemoembolization (TACE) + sorafenib therapy has been demonstrated to exert a beneficial effective on time-to-tumor-progression (TTP) in patients with unresectable hepatocellular carcinoma (HCC) in some studies. However, the beneficial effect varies among studies conducted in different areas of the world. The objectives of this study are (1) to understand whether GALNT14 TT genotype patients respond better than do GALNT14 non-TT genotype patients when treated by TACE; and (2) to understand whether GALNT14 non-TT genotype patients can benefit from TACE plus sorafenib (Nexavar) combination therapy. Patients enrolled will be stratified by GALNT14 genotyping. The GALNT14 "non-TT" patients were then randomized into two subgroups to evaluate the safety, tolerability and efficacy of TACE plus sorafenib therapy. The primary endpoint of this study is the efficacy of TACE with or without sorafenib combination therapy evaluated by complete remission (CR). The secondary endpoints are: 1. Time to partial or complete response (PR + CR). 2. Time-to-tumor-progression (TTP) and the progression free survival (PFS). 3. Overall survival (OS). 4. Safety and tolerability of TACE plus sorafenib therapy.

Timeline

Start

2015-08

Primary completion

2021-07

Completion

2021-07

Publications

• Results Liang KH, Lin CL, Chen SF, Chiu CW, Yang PC, Chang ML, Lin CC, Sung KF, Yeh C, Hung CF, Chien RN, Yeh CT. GALNT14 genotype effectively predicts the therapeutic response in unresectable hepatocellular carcinoma treated with transcatheter arterial chemoembolization. Pharmacogenomics. 2016 Mar;17(4):353-66. doi: 10.2217/pgs.15.179. Epub 2016 Feb 12.
• Chen WT, Lin SM, Lee WC, Wu TJ, Lin CC, Shen CH, Chang ML, Lin CL, Yeh CT. GALNT14 genotype-guided chemoembolization plus sorafenib therapy in hepatocellular carcinoma: a randomized trial. Hepatol Int. 2022 Feb;16(1):148-158. doi: 10.1007/s12072-021-10283-7. Epub 2022 Jan 4.

Drugs

Indications