Safety and Efficacy of Autologous Tumor-infiltrating Lymphocytes Therapy in Patients With Hepatocellular Carcinoma

Exclusion Criteria10

• 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;
• Subjects undergoing treatment with systemic steroids;
• Subjects who have previously used immune cell therapy (CIK, DC, DC-CIK, LAK therapy) and are less than 28 days from the end of treatment to screening;
• Subjects who are allergic to cell therapy products or related drugs;
• Subjects who have previously received an organ transplant or are planning to receive an organ transplant;
• Subjects requiring anticoagulant therapy (warfarin or heparin);
• Subjects who are judged by the investigator to be unsuitable for participation in this study due to other conditions.