safety and efficacy of autologous tumor-infiltrating lymphocytes therapy in patients with hepatocellular carcinoma

Conditions: Hepatocellular Carcinoma

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 at the enrollment center. exclusion criteria: 1. pregnant or breastfeeding women; 2. with hiv/aids infection; 3. active infection with a temperature \>38.3°c prior to study treatment and have been treated with antibiotics within 2 weeks prior to enrollment; 4. 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; 5. subjects undergoing treatment with systemic steroids; 6. 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; 7. subjects who are allergic to cell therapy products or related drugs; 8. subjects who have previously received an organ transplant or are planning to receive an organ transplant; 9. subjects requiring anticoagulant therapy (warfarin or heparin); 10. subjects who are judged by the investigator to be unsuitable for participation in this study due to other conditions.

Keywords: hepatocellular carcinoma tumor-infiltrating lymphocytes