Safety and Efficacy of Autologous Tumor-infiltrating Lymphocytes Therapy in Patients With Hepatocellular Carcinoma
Trial Parameters
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: 1. Aged 18 to 70 years; 2. Diagnosis of HCC with BCLC stage B/C; 3. Anticipated survival time is longer than 3 months; 4. Liver function grade Child-Pugh A or B, without hepatic encephalopathy; 5. Left ventricular ejection fraction (LVEF) ≥ 50%; 6. ECOG physical status 0-2; 7. 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. 8. 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; 9. Able to receive treatment and follow-up, including the need for the subject to receive treatment a