Hepatocellular Carcinoma
Conditions
Interventions
Treatment Group:vNKT cellular Immunotherapy
Sponsors
Shanghai Eastern Hepatobiliary Surgery Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 78 Years
Inclusion criteria
Inclusion criteria: (1) Age 18-78 years old, gender is not limited. (2) Advanced hepatocellular carcinoma that is not surgically resectable and not amenable to local therapy and that has progressed after first- and second-line therapy and meets one of the following requirements: 1) Histologically or cytologically confirmed diagnosis of HCC; 2) Clinically confirmed diagnosis of HCC according to the American Association for the Study of Liver Diseases (AASLD) criteria. patients without cirrhosis must have a histologically confirmed diagnosis of HCC. (3) Eastern Cooperative Oncology Group physical status score (ECOG) of 0 or 1. (4) Expected survival = 3 months. (5) Child-Pugh score = 6, i.e. Child-Pugh A. (6) Presence of at least one measurable lesion in the subject: evaluated according to the criteria for the evaluation of efficacy in solid tumors (RECIST V1.1). (7) Organ function levels must meet the following requirements (7 days prior to first dose of study drug). 1) Bone marrow:Absolute neutrophil count (ANC) = 1.5×109/L, platelet (PLT) = 100×109/L, hemoglobin (HB) = 9g/dL (no blood transfusion or receipt of component blood within 14 days prior to testing); 2) Liver: serum total bilirubin (TBIL) = 2 times the upper limit of normal value; aspartate aminotransferase (AST) and alanine aminotransferase (ALT) = 2.5 times the upper limit of normal value; Child-Pugh A; 3) Serum creatinine =1.5 times the upper limit of normal and endogenous creatinine clearance =50 mL/min (Cockcroft-Gault formula). 4) International normalized ratio (INR) and activated partial thromboplastin time (APTT) =1.5 times the upper limit of normal (only for patients not receiving anticoagulation; patients receiving anticoagulation should have their anticoagulant in the therapeutically required range); 5) Urine protein =1+; if urine protein >1+, 24-hour urine protein measurement should be collected and its total amount should be =1 gram; 6) Normal heart function. That is, the electrocardiogram is normal or the abnormality is not clinically significant, and the cardiac ultrasound shows that the left ventricular ejection fraction (LVEF) is greater than 50%. (8) Women of childbearing potential must have a negative serum pregnancy test within 7 days prior to the first dose of the test drug; reproductively active males or females with the potential to become pregnant must use a highly effective method of contraception (e.g., oral contraceptives, intrauterine device, abstinence from sexual intercourse, or barrier method of contraception combined with a spermicide) throughout the course of the trial and continue to be on a contraceptive regimen for 12 months after the end of treatment. (9) Subjects voluntarily enroll in the study, sign an informed consent form, are compliant, and cooperate with follow-up visits.
Exclusion criteria
Exclusion criteria: (1) Intrahepatic cholangiocarcinoma, fibroplaque-like hepatocellular carcinoma, mixed hepatocellular carcinoma, and mixed cholangiocellular carcinoma. (2) Patients who have received prior cellular immunotherapy. (3) Patients who have participated or are participating in a clinical trial of another drug/therapy within 4 weeks prior to the first dose of study drug. (4) Major surgical procedures performed/received within 4 weeks prior to first dose of study drug or have not recovered from the side effects of this procedure, live vaccination, immunotherapy, and radiotherapy within 2 weeks. (5) Patient is on immunosuppressive, or systemic hormone therapy for immunosuppression (dose >10mg/day prednisone or other equipotent hormone) that was continued within 2 weeks prior to enrollment. (6) History of malignancy other than hepatocellular carcinoma within the past 5 years, with the exception of cured basal cell carcinoma of the skin, squamous cell carcinoma of the skin, early-stage prostate cancer, and carcinoma in situ of the cervix. (7) Active inflammatory bowel disease or peptic ulcer. (8) Positive HIV antibody or syphilis spirochete antibody test results. (9) Large amount of pleural fluid or ascites with clinical symptoms and requiring symptomatic treatment. (10) Active lung disease (pneumonia, obstructive pulmonary disease, asthma) or a history of active tuberculosis. (11) Has any uncontrolled clinical problem, including but not limited to: 1) Persistent or active (severe) infection; 2) Medically poorly controlled hypertension (blood pressure persistently greater than 150/90 mmHg); 3) Poorly controlled diabetes; 4) Heart disease (class III/IV congestive heart failure or heart block as defined by the New York Heart Association); (5) The following conditions within 6 months prior to the first dose: deep vein thrombosis or pulmonary embolism; myocardial infarction; severe or unstable arrhythmia or angina pectoris; percutaneous coronary intervention, acute coronary syndromes, coronary artery bypass grafting; cerebrovascular accidents, transient ischemic attack, cerebral embolism. (12) Suffering from hematologic disorders: leukemia, lymph nodes, myelodysplastic syndromes or myeloma. (13) Immunodeficiency diseases or autoimmune diseases other than vitiligo. (14) Bleeding symptoms of significant clinical significance or a definite bleeding tendency within 3 months prior to randomization, such as coughing/hemoptysis of 2.5 ml or more per day, gastrointestinal bleeding, esophagogastric fundal varices at risk of bleeding, hemorrhagic gastric ulcers, or suffering from vasculitis. At baseline, if the fecal occult blood is positive, it may be retested. If it is still positive after review, gastroscopy is required, and if gastroscopy suggests severe esophagogastric fundal varices, the patient cannot be enrolled (except for those who have received gastroscopy to rule out such conditions within 3 months or less prior to enrollment). (15) Have obvious hereditary diseases. (16) Have received stem cell transplantation or organ transplantation. (17) Have a history of psychotropic substance abuse that cannot be stopped or have a history of mental disorder. (18) Other severe, acute or chronic medical conditions or abnormal laboratory tests that, in the judgment of the investigator, may increase the risks associated with participation in the study or may interfere with the interpretation of study results. (19) Patients who, in the judgment of the investigator,
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| overall survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective Response Rate;Disease Control Rate; | — |
Countries
China
Contacts
Public ContactKui Wang
Shanghai Eastern Hepatobiliary Surgery Hospital
Outcome results
None listed