hepatocellular carcinoma, HCC
Conditions
Interventions
Experimental group:A systemic therapeutic regimen combining iparomlimab and tuvonralimab with targeted agents, supplemented with local therapies such as TACE (Transarterial Chemoembolization) and/or H
Sponsors
The First Affiliated Hospital of Bengbu Medical University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Signed written informed consent form; 2. Age >=18 years, male or female; 3. Subjects with hepatocellular carcinoma confirmed by histopathology, cytology, or imaging; 4. Unsuitable for curative treatments such as surgical resection, ablation, or liver transplantation; 5. Subjects with HCC classified as CNLC stage IIb/IIIa/IIIb or BCLC stage B/C; 6. Child-Pugh liver function class A or B (score =3 months; 11. Organ function levels within 3 days prior to the first dose must meet the following requirements (no supportive therapy such as any blood products or colony-stimulating factors within 14 days prior to the first dose): (1) Absolute neutrophil count >=1.5×10^9/L; (2) Platelets >=90×10^9/L; (3) Hemoglobin >=90 g/L; (4) Serum albumin >=30 g/L; (5) AST and ALT 1.5×ULN, then creatinine clearance (CLcr) calculated by the Cockcroft-Gault equation must be >=50 mL/min; (8) Left ventricular ejection fraction (LVEF) >50%; (9) Proteinuria =2+, 24-hour urine protein quantification should be performed; subjects with <=1 g are eligible); (10) International normalized ratio (INR) <=1.5; activated partial thromboplastin time (APTT) <=1.5×ULN; 12. For subjects with active hepatitis B virus (HBV) infection: HBV-DNA must be <500 IU/mL (if the testing unit at the center is only copy/mL, then must be <2500 copy/mL), and the subject must have received at least 14 days of anti-HBV therapy (according to local standard of care, e.g., entecavir) prior to initiation of study treatment and be willing to continue antiviral therapy throughout the study; subjects positive for hepatitis C virus (HCV) RNA must receive antiviral therapy according to local standard treatment guidelines and have liver function within CTCAE grade 1 elevation; 13. Women of childbearing potential must have a negative pregnancy test (ß-HCG) before starting treatment; both women of childbearing potential and men (who have sexual relations with women of childbearing potential) must agree to use contraception during the treatment period and for 6 months after the last dose; 14. Subjects considered by the investigator to be likely to benefit from the study.
Exclusion criteria
Exclusion criteria: 1. Pregnant or lactating women; 2. Radiological confirmation of portal vein tumor thrombus reaching Vp3 or Vp4; 3. Patients previously treated with PD-1 antibody, PD-L1 antibody, CTLA-4 antibody, or lenvatinib; participation in other clinical trials within 30 days prior to screening. 4. Active tuberculosis infection; 5. Gastrointestinal malabsorption, gastrointestinal anastomosis, or any other condition that may affect the absorption of lenvatinib; 6. History of congestive heart failure greater than NYHA Class II, unstable angina, myocardial infarction within the past 6 months, or severe arrhythmia within the past 6 months accompanied by significant cardiovascular impairment; 7. Occurrence of gastrointestinal bleeding events or active hemoptysis (at least 0.5 teaspoon of bright red blood) within 3 weeks prior to the first dose of the study drug. 8. Presence of bleeding or thrombotic disorders, or use of Factor X inhibitors or anticoagulants requiring monitoring of INR, such as warfarin or similar agents. Use of low molecular weight heparin is permitted. Therapeutic doses of antiplatelet agents (e.g., aspirin =325 mg/day) are not allowed during the study; 9. Patients requiring immunosuppressive therapy due to organ transplantation; patients who have used immunosuppressive drugs or systemic corticosteroid therapy for immunosuppressive purposes within 14 days prior to medication (e.g., >10 mg/day prednisone or equivalent dose of other drugs); 10. Presence of active ulcers, unhealed wounds, or fractures; 11. Patients with hypertension that is not adequately controlled with antihypertensive medication (systolic blood pressure >=140 mmHg or diastolic blood pressure >=90 mmHg); 12. Known allergy to any investigational drug or excipient; 13. History of other malignancies within the past 5 years, except for those considered clearly cured or curable, such as basal cell carcinoma or squamous cell carcinoma of the skin, papillary thyroid carcinoma, localized low-risk prostate cancer, carcinoma in situ of the cervix, or carcinoma in situ of the breast, etc; 14. History of allogeneic tissue/solid organ transplantation; 15. Known history of HIV infection; 16. Other factors determined by the investigator that may affect the trial results or lead to premature termination of the study, such as alcoholism, drug abuse, other severe diseases (including mental illness) requiring combined treatment, significant laboratory abnormalities, or familial/social factors that may compromise patient safety.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of conversion to resectability;Degree of tumor shrinkage; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate ;Disease control rate ;Progression-free survival ;Overall survival ;Security; | — |
Countries
China
Contacts
Public ContactMing Xu
The First Affiliated Hospital of Bengbu Medical University
Outcome results
None listed