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;
Pregnant or breastfeeding women;
WIth HIV/AIDS infection;
Active infection with a temperature >38.3°C prior to study treatment and have been treated with antibiotics within 2 weeks prior to enrollment;
Presence of the following pre-existing or concomitant diseases: Prior diagnosis of a severe autoimmune disease requiring systemic immunosuppression (steroids) for a prolonged period of time (more than 2 months), or immune-mediated symptomatic disease; Prior diagnosis of autoimmune-induced motor neuron disease; Prior toxic epidermal necrolysis release; Subjects with any psychiatric condition, including dementia, altered mental status, which may interfere with treatment in this study; Subjects with other malignancies in the previous 5 years; Subjects with heart failure ≥ grade 2 (NYHA) or hypertension uncontrolled by standard therapy; Subjects with unstable or active peptic ulcer or gastrointestinal bleeding; Subjects with serious uncontrollable disease, as determined by the study, that may interfere with treatment in this study;
Single group
Autologous Tumor-infiltrating Lymphocytes
Procedure/SurgeryAutologous Tumor-infiltrating Lymphocytes, 2.0\*10\^7/Kg, single intravenous infusion.
Incidence of Treatment-Emergent Adverse Events
Safety and Tolerability of Autologous Tumor-infiltrating Lymphocytes Therapy
Concentration of Total Bilirubin (TBIL, mg/dL)
Total bilirubin refers to the concentration of bilirubin in a patient's blood sample, which is automatically measured by the laboratories in accordance with standard operating procedures.
Child-Turcotte-Pugh(CTP) score
CTP score is currently the most commonly used model to evaluate liver reserve function and prognosis in patients with cirrhosis. This model evaluates liver function based on HE grade, degree of abdominal fluid accumulation, bilirubin (TBiL), albumin (Alb) and prothrombin time (PT). The score ranges from 0 to 15, with the higher the score, the worse the prognosis.
Quality of life of patients
Quality of life assessed by Functional Assessment of Cancer Therapy - Hepatobiliary Symptom Index， which has a score ranges 0-32, a higher score indicates better quality of life.
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