Hepatocellular carcinoma
Conditions
Interventions
Tyrosine kinase inhibitors (TKIs): Administration at the investigator's discretion.
Sponsors
Huaibei People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Signed written informed consent form (ICF). 2.Age >= 18 years, male or female. 3.Patients with advanced hepatocellular carcinoma (HCC) confirmed by histopathology, cytology, or radiology. 4.Patientsnmust have experienced disease progression after prior immunotherapy, including ati-PD-1/PD-L1 monotherapy or in combination with other checkpoint inhibitors or therapies. 5.Barcelona Clinic Liver Cancer (BCLC) stage B/C HCC. 6.Child-Pugh liver function class A to B (score = 3 months. 10.Key organ function within 3 days prior to the first dose must meet the following criteria (no supportive therapy, including blood products, within 14 days prior to the first dose): a) Absolute neutrophil count (ANC) >= 1.5×10^9/L. b) Platelet count >= 75×10^9/L. c) Hemoglobin >= 90 g/L. d) Serum albumin >= 30 g/L. e) AST and ALT 1.5×ULN, creatinine clearance (CLcr) calculated by Cockcroft-Gault formula must be >= 50 mL/min. h) Left ventricular ejection fraction (LVEF) >50%. i) Proteinuria = 2+, 24-hour urine protein must be = 14 days prior to study treatment, with continued antiviral therapy throughout the study. Hepatitis C virus (HCV) RNA-positive patients must receive antiviral therapy per local guidelines, with liver function <= CTCAE grade 1. 12.Women of childbearing potential (WOCBP) must have a negative serum ß-HCG pregnancy test before treatment initiation. Both WOCBP and male patients (with partners of childbearing potential) must agree to use contraception during treatment and for 6 months after the last dose. 13.Patients deemed eligible by the investigator
Exclusion criteria
Exclusion criteria: 1.Known cholangiocarcinoma, sarcomatoid HCC, mixed cell carcinoma, or fibrolamellar carcinoma. 2.History of other active malignancies (except HCC) within 5 years or concurrent diagnosis. Patients with cured localized tumors (e.g., basal cell carcinoma, squamous cell carcinoma of the skin, superficial bladder cancer, carcinoma in situ of the cervix/prostate/breast) may be enrolled. 3.Toxicity from prior anticancer therapy not resolved to = Grade 3 toxicity or other immune-related adverse events. 5.Child-Pugh class C liver function. 6.Hepatic tumor burden exceeding 50% of total liver volume, or presence of inferior vena cava/mesenteric vein tumor thrombus. 7.Contraindications to targeted agents or immune checkpoint inhibitors. 8.Severe comorbidities, including significant cardiac, pulmonary, renal, or coagulation dysfunction, or major cardiovascular diseases (e.g., unstable arrhythmia, unstable angina, myocardial infarction). 9.Pregnant or lactating women. 10.Active systemic infection requiring intravenous antibiotics >7 days within 2 weeks prior to the first dose, unexplained fever >38.5°C during screening (unless deemed tumor-related by the investigator). 11.Diagnosed immunodeficiency or systemic corticosteroid/immunosuppressive therapy within 7 days prior to the first dose. 12.Clinically significant bleeding within 6 months (e.g., gastrointestinal bleeding, severe esophageal varices, hemorrhagic gastric ulcer, vasculitis). For baseline occult blood-positive stool, repeat testing and gastroscopy required if persistently positive. 13.Hereditary/acquired bleeding/thrombotic disorders (e.g., hemophilia, thrombocytopenia). Current therapeutic-dose anticoagulants or thrombolytics (prophylactic low-dose aspirin allowed). 14.Arterial thromboembolic events within 6 months (e.g., stroke, transient ischemic attack, CTCAE >= Grade 3 deep vein thrombosis, pulmonary embolism). 15.Symptomatic central nervous system (CNS) metastases. 16.Active or recurrent autoimmune diseases. 17.Interstitial lung disease (ILD), pneumoconiosis, radiation pneumonitis with clinical significance per investigator, or severe pulmonary dysfunction interfering with drug-related pulmonary toxicity assessment. 18.HIV-positive status:anti-tuberculosis therapy within 1 year,active syphilis infection. 19.Clinically significant ascites or pleural effusion requiring intervention. 20.Live vaccination within 4 weeks prior to the first dose. 21.Participation in other clinical trials with investigational drugs within 4 weeks prior to the first dose. 22.History of substance abuse, alcoholism, or drug addiction neurological/psychiatric disorders (e.g., epilepsy, dementia, hepatic encephalopathy). 23.Hypersensitivity to macromolecular protein preparations or any component of the investigational product. 24.Other conditions deemed ineligible by the investigator due to increased study risks or interference with result interpretation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-Free Survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival;Objective Response Rate;Disease Control Rate;Adverse Events;Duration of Response; | — |
Countries
China
Contacts
Public ContactWang Ya
Huaibei People's Hospital
Outcome results
None listed