HCC
Conditions
Interventions
A group:HH-009 Injection 30mg/kg
B group:HH-009 Injection 20mg/kg
Sponsors
Nanjing Tianyinshan Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Voluntarily participate in the clinical trial and sign the informed consent form. 2. Age 18–75 years (inclusive), any gender. 3. Patients with advanced or unresectable HCC confirmed by pathological histology or meeting the clinical diagnostic criteria specified in the guidelines of the National Health Commission, and also meeting the following requirements: (1) HCC patients who experienced disease progression after previous first-line systemic therapy containing immune checkpoint inhibitors; (2) Tumor tissue tested positive for FGF19 by IHC (confirmed by central laboratory); (3) Liver reserve function of Child-Pugh class A or well-compensated class B (=12 weeks. 7. Adequate organ and bone marrow function: (1) Blood routine: absolute neutrophil count (ANC) >=1.5×10^9/L, platelet count (PLT) >=80×10^9/L, and hemoglobin (HGB) >=90 g/L; (2) Liver function: total serum bilirubin =60.0 mL/min calculated by the Cockcroft-Gault formula (Appendix 5); (4) Coagulation function: international normalized ratio (INR) <=1.5 and activated partial thromboplastin time (APTT) <=1.5×ULN (for subjects on anticoagulant therapy, the investigator determines that INR and APTT are within a safe and effective therapeutic range). 8. Subjects with hepatitis C virus (HCV) infection, with HCV-RNA above the lower limit of detection of the study center, may be included if antiviral treatment is administered before the first dose. 9. Subjects with hepatitis B virus (HBV) infection are required to have HBV-DNA < 10^4 cps/ml or 2000 IU/ml. 10. Subjects (including partners) are willing to use effective contraception from the screening period until 6 months after the last study dose.
Exclusion criteria
Exclusion criteria: 1. Participation in other investigational drug or device clinical trials within 28 days prior to the first dose; or receiving antitumor therapy within 4 weeks prior to the first dose or within 5 half-lives of the drug (whichever is shorter), including but not limited to chemotherapy, radiotherapy (palliative radiotherapy completed at least 2 weeks before investigational drug treatment is permitted), targeted therapy, immunotherapy, or endocrine therapy; receiving Chinese medicine with antitumor indications within 1 week prior to the first dose. 2. Toxic reactions from previous antitumor treatments have not resolved to 450 ms, female >470 ms (Appendix 7); cerebrovascular symptoms within 6 months prior to screening such as cerebral infarction, cerebral hemorrhage, transient ischemic attack; hypertension uncontrolled by antihypertensive therapy (resting systolic bloo
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression Free Survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective Response Rate;Disease Control Rate;Duration of Response;Time to Progression;Time to Response;Overall Survival; | — |
Countries
China
Contacts
Public ContactXun Chen
Nanjing Tianyinshan Hospital
Outcome results
None listed