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

• Status: Recruiting
• Trial end date: 2021-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Beijing YouAn Hospital
• Treatments: Cyclophosphamide; Interleukin-2

Criteria

Inclusion Criteria:

• Age 18-80 years.

• Patients with hepatocellular carcinoma (BCLC, stage C) proved by histopathology or proved by CT or MRI imaging system, relapsed after previous therapy and no effective therapies known at this time.

• Life expectancy of ≥ 12 weeks.

• WBC>3.0×10^9/L, LYMPH> 0.8×10^9/L, Hb>85g/L, PLT>50×10^9/L, Cre<1.5×the upper limit of normal value.

• iNKT>10/mL in peripheral blood mononuclear cell (PBMC).

• Able to understand and sign the informed consent.

Exclusion Criteria:

• Any uncontrolled systematic disease: hypertension, heart disease, and et al.;

• Portal vein tumor thrombus, central nervous system tumor metastasis, or combined with other tumors;

• Receiving radiochemotherapy, local therapy, or targeting drugs within 4 weeks prior to this treatment;

• Unstable immune systematic diseases or infectious diseases;

• Combined with AIDS or syphilis;

• Patients with history of stem cell or organ transplantation;

• Patients with allergic history to related drugs and immunotherapy;

• Patients with complications associated with liver diseases: moderate or severe pleural effusion, pericardial effusion, ascites, or gastrointestinal hemorrhage;

• Pregnant or lactating subjects;

• Unsuitable subjects considered by clinicians.