Spots Global Cancer Trial Database for Study of Adoptive Transfer of iNKT Cells Combined With TACE to Treat Advanced HCC

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Trial Identification

Brief Title: Study of Adoptive Transfer of iNKT Cells Combined With TACE to Treat Advanced HCC

Official Title: Study of Adoptive Transfer of Invariant Natural Killer T Cells Combined With Transcatheter Arterial Chemoembolization (TACE) to Treat Advanced Hepatocellular Carcinoma (HCC): Phase II Clinical Trial

Study ID: NCT04011033

Conditions

Hepatocellular Carcinoma

Interventions

iNKT cells

Cyclophosphamide

Human recombinated Interleukin-2

TACE

Study Description

Brief Summary: Hepatocellular carcinoma (HCC) is a common disease with high mortality. More than 80% patients are first diagnosed with late-stage and unresectable, their effective drugs and treatments are very limited. invariant Natural Killer T (iNKT) cell exhibit antitumor activity against malignant tumors through producing high levels of cytokines. iNKT cells are abundant in the liver, but defect in liver cancer development. iNKT cells can express homing receptors licensing them specifically to migrate liver, then play key antitumor immunity. We already did a phase I study of autologous infusion of iNKT cells in the treatment of patients with advanced HCC. Safety and feasibility of iNKT infusion was proved. The purpose of this study is to verify the effectiveness of iNKT cells infusion combined with transcatheter arterial chemoembolization (TACE) in treatment of advanced HCC.

Detailed Description: Patients with advanced HCC will be enrolled and divided into two groups. Patients in experimental group will be treated with TACE combined with iNKT cells infusion. TACE will be performed at 0th and 4th week. iNKT cells will be infused at 1st, 3rd, 5th, 7th, 8th and 12th week. Patients in control group will be treated with TACE at 0th and 4th week. Adverse events（AEs）, overall survival (OS) time and recurrence-free survival (RFS) time, change of immune cells will be monitored.