Hepatocellular carcinoma
Conditions
Interventions
Dose group 2:1.0mg/kg
Dose group 1:0.5mg/kg
Dose group 3:1.5mg/kg
Sponsors
People's Hospital of Deyang City
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.18 years old = 10mm or the short diameter of the enlarged lymph node is >= 15mm), or the measurable lesion with definite progression after local treatment (based on RECIST 1.1 criteria); 4.The investigator planned to prescribe or actually prescribed tirelizumab injection; 5.Hepatocellular carcinoma was unresectable, Barcelona clinical liver cancer stage (BCLC stage) B, C and China clinical liver cancer stage (CNLC stage) ? B, ? a, ? B; 6.At least 6 white films should be available to detect that both crept and ASGPR receptors are positive in liver cancer tissues; Or the tumor tissue can be obtained by puncture and sectioned to determine the double positive of crept and ASGPR. The H-score was more than 50%, and the staining intensity was 2 +; 7.Child Pugh liver function rating: Grade A or better grade B (=90g/L; b) neutrophil >=1.5×10^9/L; c) platelet count >=75×10^9/L; (2) Liver function: ALT and AST=28g/L; Total bilirubin (TBIL) <=2×ULN; Alkaline phosphatase (ALP) <=5×ULN; (3) Renal function: serum creatinine (Cr) <=1.5×ULN or creatinine clearance rate 12.Sign written informed consent, and be able to follow the visit and relevant procedures specified in the plan.
Exclusion criteria
Exclusion criteria: 1.Fibrolamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, hepatocholangiocarcinoma, mixed liver cancer, etc. previously confirmed by histology or cytology; 2.Have a history of hepatic encephalopathy or liver transplantation; 3.Patients with portal vein tumor thrombus involving both the main trunk and superior mesenteric vein, or with inferior vena cava tumor thrombus or cardiac involvement; 4.Other malignant tumors diagnosed within 5 years before the first administration do not include skin basal cell carcinoma, skin squamous cell carcinoma and / or carcinoma in situ that has undergone radical resection; 5.Moderate or severe ascites or pleural effusion, ascites and pericardial effusion with clinical symptoms requiring drainage within 4 weeks before the first administration; 6.Before the first dose of study treatment, there was toxicity caused by previous treatment that did not return to NCI CTCAE version 5.0 grade 0 or 1 (excluding alopecia, non clinically significant and asymptomatic laboratory abnormalities); 7.Received systemic anti-tumor treatment within 4 weeks before the first administration of this study treatment, including chemotherapy, radiotherapy, biotherapy, cytokine therapy, immunotherapy or participated in other therapeutic clinical studies (except observational clinical studies); Or received nitrosourea drugs or mitomycin C treatment within 6 weeks before the first administration. Except for the following cases: 1) having received oral fluorouracil drugs or small molecule targeted agents 2 weeks before the first administration or more than 5 half lives from the last Administration (whichever is longer, no more than 28 days); 2) ; 3) Palliative bone directed radiotherapy. 8.Poorly controlled patients with acute or chronic active hepatitis B or C infection; 9.With known active central nervous system metastasis (CNS) and / or cancerous meningitis: subjects with brain metastasis who have received previous treatment can participate in the study, provided that they are clinically stable for at least 2 weeks, have no evidence of new or expanded brain metastasis, and discontinue steroids 14 days before study drug administration. Stable brain metastases in this definition should be determined before the first administration of the study drug. Subjects with asymptomatic brain metastases (i.e. no neurological symptoms, no corticosteroids, and no lesions > 1.5cm) can participate, but they need to have brain imaging examinations regularly as the disease site; 10.Bleeding events of esophageal or gastric varices caused by portal hypertension occurred within 6 months before screening. The presence of severe varicose veins on endoscopy was known within 3 months before the first administration. There was evidence of portal hypertension, and the investigator assessed that the risk of bleeding was high; 11.Any life-threatening bleeding event occurred 3 months before screening, including the need for blood transfusion treatment, surgery or local treatment, and continuous drug treatment; Have severe bleeding tendency or coagulation dysfunction, or are receiving thrombolytic therapy; 12.Arterial and venous thromboembolic events within 6 months before screening, including history of myocardial infarction, unstable angina pectoris, cerebrovascular accident or transient ischemic attack, pulmonary embolism, deep vein thrombosis or any other serious thromboembolism. Implantable venous port or catheter-derived thrombosis, or su
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety assessment; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetics;Immunogenicity;Evaluation of effectiveness;Pharmacodynamics; | — |
Countries
China
Contacts
Public ContactGang Mai
People's Hospital of Deyang City
Outcome results
None listed