liver cancer
Conditions
Interventions
3:iv
Sponsors
The First Affiliated Hospital of Zhengzhou University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-65 years, gender is not limited. 2. Subjects with hepatocellular carcinoma diagnosed by histology/cytology, who are not suitable for surgery or local therapy, and who have failed or cannot tolerate standard systemic therapy, and who have no effective treatment at the time of enrollment (Systemic therapy includes but is not limited to systemic chemotherapy, molecular targeted therapy, surgery, interventional therapy, radiotherapy, etc.); definition of intolerance: hematological toxicity of grade >=IV or non-hematological toxicity of grade >=III or damage to major organs such as heart, liver, kidney, etc. of grade >=II during treatment; definition of treatment failure: disease progression (PD) during treatment or recurrence after the end of treatment (including postoperative recurrence). 3. The tumor tissue sample is GPC3 positive (IHC test). 4. At least one evaluable lesion (according to RECIST1.1), non-lymph node lesions >= 1.0cm in length, or lymph node lesions >= 1.5cm, of which intrahepatic lesions require arterial phase enhancement imaging. 5. The Barcelona Clinic Liver Cancer (BCLC) staging system is stage C or stage B where local therapy is not suitable or local therapy has failed. 6. Child-Pugh score A or good B (= 12 weeks. 9. Normal function of major organs: (1) Blood routine: white blood cell count >=3x10^9/L, absolute neutrophil count (ANC) >=1.5x10^9/L; hemoglobin (Hb) >=85g/L; platelet count >=80x10^9/L (No blood transfusion or correction with hematopoietic factors and other drugs in the 14 days before enrollment); (2) Blood biochemistry: albumin (ALB) >= 28g/L; aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP) <= 5 times the upper limit of normal (ULN), total bilirubin (TBIL) and creatinine (cCr) were both <=1.5 times the upper limit of normal (ULN). 10. Women of childbearing age must undergo a serological pregnancy test during the screening period and within 14 days before the reinfusion of cells, and the result is negative; and are willing to use reliable methods of contraception during the test and 12 months after cell infusion; male subjects whose partners are women of childbearing age should undergo surgical sterilization or agree to use a reliable method of contraception during the trial and for 12 months after cell infusion. 11. The subjects voluntarily joined the study, signed the informed consent form, had good compliance, and cooperated with the follow-up.
Exclusion criteria
Exclusion criteria: 1. Active infection that is difficult to control; 2. HIV antibody positive, syphilis serological test positive; 3. Past or current hepatic encephalopathy; 4. Have a history of organ transplantation; 5. Those who are receiving systemic steroid therapy (>=0.5mg/kg/day methylprednisolone or equivalent), if considering enrollment, dose adjustment or drug withdrawal should be made at least 72 hours before cell infusion (excluding inhaled corticosteroids); 6. The toxicity or complications caused by previous intervention or treatment have not recovered to grade 1 or below (except for alopecia); 7. Imaging results show that >50% of the liver has been occupied by tumor, or hepatic portal vein tumor thrombus, or mesenteric/inferior vena cava-tumor thrombus invasion; 8. Received other gene therapy products in the past, or are passing or participating in other clinical trials, including but not limited to immune checkpoint inhibitors (PD-1/PDL-1 antibodies), targeted drugs, radiotherapy, chemotherapy and local therapy ; 9. Clinically diagnosed with thyroid dysfunction of grade >=3 (CTCAEv5.0); 10. Active autoimmune diseases known to require systemic therapy or immunosuppressive therapy including biological agents; 11. Clinically significant, uncontrollable ascites; 12. Diagnosed with other malignant tumors within 3 years before screening, except for those who have been treated for basal cell carcinoma of the skin, squamous cell carcinoma of the skin and/or have undergone radical resection of carcinoma in situ; 13. There is a history or any evidence of central nervous system (CNS) metastasis and/or cancerous meningitis (as assessed by the investigator, those with stable disease can be considered for inclusion); 14. Those with mental illness or history of drug abuse; 15. Breastfeeding women; 16. The investigator believes that there are other factors that are not suitable for inclusion or that affect subjects participating in or completing the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety; | — |
Countries
China
Contacts
Public ContactZhang Yi
The First Affiliated Hospital of Zhengzhou University
Outcome results
None listed