HCC
Conditions
Interventions
Intervention group:CG-102-12
Sponsors
The First People's Hospital of Lianyungang
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1)Subjects were fully aware of the possible risks and benefits of participating in this study and signed an informed consent form; 2)Age 18-75 years old (including 18 and 75 years old); 3) Patients with GPC3-positive advanced hepatocellular carcinoma (HCC) diagnosed by pathological histology or cytology (advanced HCC is defined as stage C according to the Barcelona Criteria for the Classification of Liver Cancer (BCLC) or stage B unsuitable for local treatment/progression of local treatment (local treatment includes ablation therapy, intervention and radiotherapy)) who have previously received standard systemic treatment and have either failed treatment or are intolerance (systemic therapy includes, but is not limited to, systemic chemotherapy, molecular targeting, and other therapies). Treatment failure is defined as disease progression during or after the most recent treatment; 4)GPC3-positive by immunohistochemical assay of tumor tissue samples (defined as a percentage of GPC3-positive cells >25% and staining =1+ by IHC of the pathology specimen), with a preference for the target lesion specimen, including freshly obtained tumor pathology samples or archived tumor pathology samples that are acceptable in the judgment of the investigator; 5) Child-Pugh score = 7; 6) At least one evaluable tumor lesion as assessed by mRECIST; 7)ECOG physical status score of 0-1; 8)Expected survival = 3 months; 9)Blood tests meeting the following criteria: ANC = 1.5 x 109/L; HGB = 9 g/dL; PLT = 50 x 109/L (must not have received growth factors or transfusion therapy within 7 days prior to laboratory tests); 10)Blood biochemistry tests meeting the following criteria: TBIL = 2.5 times ULN; AST and ALT = 5.0 times ULN; serum albumin = 28 g/L, serum creatinine = 1.5 times ULN, and creatinine clearance > 50 mL/min (based on the Cockcroft Gault formula); 11) Coagulation meets the following criteria: INR < 1.5 times ULN, APTT < 1.5 times ULN, and PT prolongation = 4 s; 12) If the patient is HBsAg positive or HBcAb positive, HBV-DNA = 2000 IU/mL needs to be met; 13) Negative blood pregnancy test in female subjects of childbearing potential at screening, 3 days prior to single component blood collection and pretreatment; subjects of childbearing potential and their partners must use effective contraception during the study and for at least 1 year after completion of study treatment.
Exclusion criteria
Exclusion criteria: 1) History of a second primary malignancy, unless the patient has received potentially curative therapy and there is no evidence of the disease within 5 years; Note: This time requirement (i.e., within 5 years) does not apply to adequately treated patients with cervical carcinoma in situ, limited squamous cell carcinoma of the skin, basal cell carcinoma, limited prostate cancer, ductal carcinoma in situ of the breast, or <T1 epithelial carcinoma of the urothelium; patients with prostate cancer under active surveillance are also eligible. 2)Prior CAR-T or TCR-T cell therapy or therapeutic tumor vaccine targeting any target; or prior therapy of any kind targeting GPC3; 3) Received the following anti-tumor therapy prior to single component blood collection: Cytotoxic therapy within 14 days; Received small molecule targeted therapy, epigenetic therapy, or experimental drug therapy within 14 days or at least 5 half-lives, whichever is longer, or treatment with an invasive experimental medical device; Treatment with monoclonal antibodies within 21 days; Treatment with immunomodulators within 7 days; Received radiotherapy within 14 days. 4) Toxic response to prior antineoplastic therapy that has not recovered to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE version 5.0) = Grade 1, with the exception of alopecia areata, Grade 2 peripheral neuropathy, and hypothyroidism controlled by hormone replacement therapy; 5)Have received a previous organ transplant or are awaiting an organ transplant (including liver transplant); 6)have brain metastases with central nervous system symptoms or the presence of other clinically significant central nervous system disease; 7)have a history of hepatic encephalopathy or the current presence of hepatic encephalopathy; 8)the presence of ascites requiring therapeutic intervention (excluding any ascites demonstrated by imaging that does not require clinical intervention); 9)Patients with HCC tumor tissue volume comprising =50% of normal liver volume based on imaging, or the presence of a cancerous thrombus in the main portal or vena cava trunk, or who, in the judgment of the investigator, are not suitable for enrollment; 10)Pregnant or lactating women; 11)Patients who screen positive for either hepatitis C antibody (HCV-Ab) or human immunodeficiency virus antibody (HIV-Ab); those with active syphilis; (patients who are positive for HCV antibody but have HCV-RNA < the lower limit of detection at the study center are permitted to be enrolled); 12) Have a serious underlying medical condition, for example: Evidence of severe active viral or bacterial infection or uncontrolled systemic fungal infection; Active or unstable autoimmune disease or autoimmune disease that has been present within 3 years and is likely to recur (e.g., the following, but not limited to: autoimmune hepatitis, interstitial pneumonitis, uveitis, enterocolitis, hepatitis, pituitary gland inflammation, vasculitis, nephritis, and hyperthyroidism; patients with vitiligo; asthma that has been in complete remission in childhood and does not require any adult intervention can be included; patients with asthma requiring medical intervention with bronchodilators cannot be included); Uncontrolled diabetes mellitus; Patients with severe congestive heart failure in New York Heart Association (NYHA) class II or higher or with an ejection fraction of less than 50%; patients with a history of my
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Tumor Size;Alpha-fetoprotein; | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of treament emergent adverse events; | — |
Countries
China
Contacts
Public ContactJiang Xiaodong
The First People's Hospital of Lianyungang
Outcome results
None listed