Safety and Efficacy of Autologous Tumor-infiltrating Lymphocytes Therapy in Patients With Hepatocellular Carcinoma
This is a Phase 1, open label clinical trial of tumor-infiltrating lymphocytes for the treatment of patients with hepatocellular carcinoma. The purpose of this study is to assess the safety of tumor-infiltrating lymphocytes therapy in patients with hepatocellular carcinoma.
• Aged 18 to 70 years;
• Diagnosis of HCC with BCLC stage B/C;
• Anticipated survival time is longer than 3 months;
• Liver function grade Child-Pugh A or B, without hepatic encephalopathy;
• Left ventricular ejection fraction (LVEF) ≥ 50%;
• ECOG physical status 0-2;
• Laboratory tests at baseline meet the following: Absolute neutrophil count \>1.0 x 109/L; Absolute neutrophil count \>1.0 x 109/L; White blood cell count \> 2.0 x 109/L; Platelet count \> 60 x 109/L; Hgb \> 8.0 g/dL; ALT and AST ≤ 5 times the upper limit of normal (ULN), Serum total bilirubin (TBiL) ≤ 51 mmol/L, or \< 3 times the ULN.
• Female subjects of childbearing potential must take acceptable measures to minimize the likelihood of pregnancy during the trial. Female subjects of childbearing potential must have a negative serum or urine pregnancy result within 48 hours prior to treatment;
• Able to receive treatment and follow-up, including the need for the subject to receive treatment at the enrollment center.