Hepatocellular carcinoma
Conditions
Interventions
Experimental group:ZiCAR-002 cell therapy
Sponsors
the Affiliated Drum Tower Hospital,Medical School of Nanjing University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Patients who are willing to participate in the study can understand and sign the informed consent; 2. The tumor tissue was identified as primary hepatocellular carcinoma by immunohistochemical detection; 3. Hepatocellular carcinoma with GPC3 positive expression greater than 25% of tissue samples collected within one year were detected by immunohistochemistry; 4. Aged between 18 and 70; 5. Patients with advanced liver cancer confirmed by histopathology or cytology who are not candidates for surgery or local therapy (including ablative therapy, access, and radiotherapy) and who have developed progression or intolerance after prior systemic therapy (systemic therapy) Treatment includes but is not limited to systemic chemotherapy, molecular targeting and other therapies), and there is no effective treatment at the time of enrollment; 6. Stage C according to the Barcelona Scale of liver Cancer (BCLC) or B not suitable for local treatment/local treatment progression; 7. If the patient is HBsAg positive or HBcAb positive, HBV-DNA < 500IU/ml should be satisfied. HBsAg positive patients must receive antiviral therapy according to the Chronic Hepatitis B Prevention Guidelines 2015 Edition. 8. The expected survival is not less than 12 weeks; 9. At least one measurable lesion (maximum diameter of non-lymph node lesion =10mm, or minimum diameter of lymph node =15mm) 10. The liver function was Child-Pugh grade A; 11. ECOG physical condition score is 0-1; 12. Routine blood test reached the following indicators: WBCs (white blood cell count) =2.0×109/L; PLT (platelet count) = 50×109/L; Hb (hemoglobin) = 90 g/L; Lymphocyte ratio =15%, lymphocyte count = 500 /ul or CD3-positive T cell number = 150 /ul; ANC (neutrophil count) = 1.5×109/L; No treatment with G-CSF, TPO or EPO was received within 2 weeks. Did not receive blood transfusion within 2 weeks; 13. Blood biochemistry: Serum Alb= 30g/L; Serum creatinine = 1.5ULN; Endogenous creatinine clearance = 40mL/min; ALT= 5ULN; AST= 5ULN; Total bilirubin = 2.5ULN; Prothrombin time extension = 4s; 14. Capable of normal venous blood collection and machine simple collection, capable of lymphocyte clearance therapy
Exclusion criteria
Exclusion criteria: 1. Pregnant or lactating female patients; 2. Patients with brain metastases; 3. Patients with past or current hepatic encephalopathy; 4. Imaging examination results: cancer thrombus in main portal vein, or cancer thrombus invading mesenteric vein/inferior vena cava; 5. Patients with active infectious diseases, including HIV antibody positive, treponema pallidum specific antibody positive, active tuberculosis, active hepatitis C, (HCV antibody positive but hcV-RNA 300mg/d; Clopidogrel > 75 mg/d); 28. Patients with organ failure or dysfunction: ? Cardiac function: Cardiac function grade 3 or above (according to NYHA standards of the New York College of Cardiology) Left ejection fraction (LVEF) < 45%; ? Lung function: respiratory failure; ? Brain function: central nervous system abnormalities or disturbance of consciousness; 29. Patients suffering from any serious, uncontrollable disease 30. Patients with a history of acute drug allergy, especially to immunoglobulin drugs; 31. Patients with a history of other tumors within 5 years (except those who have been completely cured and do not require follow-up treatment); 32. Patients who are participating in other clinical trials; 33. The investigators consid
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Liver/tumor-related blood indicators;Number of peripheral blood CAR copies;Peripheral blood lymphophenotype; | — |
Countries
China
Contacts
Public ContactDecai Yu
the Affiliated Drum Tower Hospital,Medical School of Nanjing University
Outcome results
None listed