Hepatocellular carcinoma
Conditions
Interventions
single arm:Infusion of tumor infiltrating lymphocytes via hepatic artery catheter
Sponsors
Beijing Aerospace Center Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Men or women aged 18-70 or older. 2. Patients with HCC definitely diagnosed and BCLC stage is stage C. 3. The expected survival time is more than 3 months. 4. Patients' liver function grade B, no hepatic encephalopathy. 5. Left ventricular ejection fraction (LVEF) >= 50%. 6. ECoG physical state 0-2. 7. Baseline laboratory examination (repeated laboratory examination is allowed during screening to evaluate the qualification of subjects, and laboratory results must be within the scope of the protocol before study treatment) ·Absolute count of neutrophils > 1.5 x 10^9 ·Leukocyte count > 1.9 x 10^9 ·Platelet count > 100 x 10^9 ·HGB > 8.0 g / dl (< 8.0 g / dl, the hemoglobin value is stable, the cardiovascular system of the subject is in a stable state, without symptoms, and the subject can undergo the procedure of hepatic artery catheterization according to the judgment of the researcher) ·ALT and AST <= 5 times upper limit of normal value (ULN) ·TBIL <= 3.0ng/dl, or < 2.5 times ULN Note: if clinically proven, subjects can receive platelet or concentrated RBC infusion, and can be reevaluated after treatment. 8. Patients volunteerly participate in the study and have ability to sign informed consent. 9. Have ability to receive treatment and follow-up, including the need for subjects to receive treatment at the Enrollment Center. 10. Women of childbearing age must take acceptable measures to minimize the possibility of pregnancy during the trial. The pregnancy result of serum or urine in 48 hours before treatment must be negative.
Exclusion criteria
Exclusion criteria: 1. Pregnant or lactating women. 2. HIV / AIDS infection. 3. There is active infection. The body temperature is more than 38.3 degrees C immediately before the study and treatment, and antibiotics have been used in the first month before the study. 4. Subjects with the following previous or concomitant diseases: ·Patients with severe autoimmune diseases need systemic immunosuppressive agents (steroids) or immune-mediated symptomatic diseases for a long time (more than 2 months), including ulcerative colitis, Crohn's disease, rheumatoid arthritis, systemic lupus erythematosus, autoimmune vasculitis (such as Wegener's granulomatosis); ·Subjects previously diagnosed with motor neuron disease caused by autoimmunity; ·Subjects with previous moderate toxic epidermal necrolysis (ten); ·Subjects with any mental illness, including dementia and change of mental state, may affect the treatment of this study; ·Patients with serious uncontrollable diseases determined by the study may affect the treatment of this study; ·Subjects with other malignancies in the past 5 years. 5. Subjects who are being treated with systemic steroids or steroid inhalers. 6. Subjects who had previously used gene therapy drugs. 7. Subjects who had previously used tumor immunotherapy (CIK, DC, DC-CIK, LAK) and were less than 28 days old from the end of treatment to the time of screening. 8. Subjects are allergic to immunotherapy or related drugs. 9. Subjects are allergic to iodinated contrast media. 10. Subjects with heart failure >= Level 2 (NYHA) or hypertension beyond the control of standard treatment and requiring special treatment. 11. Subjects with unstable or active peptic ulcer or gastrointestinal bleeding. 12. Subjects who have received or are about to receive organ transplants before. 13. Subjects requiring anticoagulation (warfarin or heparin). 14. Subjects not suitable for this study are judged by the researchers.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease control rate;Progression free survival;Overall survival time;Incidence of adverse reactions; | — |
Countries
China
Contacts
Public ContactMingchao Ding
Beijing Aerospace Center Hospital
Outcome results
None listed