Spots Global Cancer Trial Database for A Study of LioCyx in Patient With Recurrent HBV-related HCC Post Liver Transplantation

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Trial Identification

Brief Title: A Study of LioCyx in Patient With Recurrent HBV-related HCC Post Liver Transplantation

Official Title: A Phase I/II, Open Label, Single Arm, Multicenter Study of LioCyx in Subjects With Recurrent Hepatitis B Virus-Related Hepatocellular Carcinoma Post Liver Transplantation

Study ID: NCT03634683

Conditions

Recurrent Hepatocellular Carcinoma

Interventions

LioCyx

Study Description

Brief Summary: Hepatocellular carcinoma (HCC) represent approximately 70-85% of liver cancer, in which Hepatitis B virus (HBV) is the major etiologic agent accounting for at least 80% of HCC in Asian countries. Overall, transplantation remains the best option however, HCC recurrence rate is high among liver transplant patients. While there are limited treatment measures for HBV-related HCC recurrences, the study hypothesized that LioCyx is capable of lysing target liver cells expressing the HBV cognate antigens and provide clinical benefit to patients with HBV-related HCC.

Detailed Description: The study is a Phase I/II, open label, single-arm, multicenter study of LioCyx. Subjects with recurrent hepatitis B virus-related hepatocellular carcinoma who undergone liver transplantation will be enrolled. Approximately 6-12 subjects will be enrolled in Phase 1 dose regimen exploration, and approximately 60 subjects will be enrolled to characterize the safety and evaluate the efficacy of LioCyx" All subjects will be followed up for survival until death.