hepatocellular carcinoma
Conditions
Interventions
Trial group: iparomlimab and tuvonralimab injection in combination with lenvatinib mesilate capsules
Sponsors
The First Affiliated Hospital of Zhengzhou University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age >= 18 and =1.5×10^9/L; PLT >=75×10^9/L; Hb >=90g/L; (2) Biochemical investigation should meet the following criteria: TBIL = upper limit of normal (ULN); ALT and AST = 50 mL/min (Cockcroft Gault formula); (3) The standard of coagulation examination should meet: international normalised ratio (INR) or prothrombin time (PT) = 55%); 10. Female patients who have not undergone menopause or surgical sterilization: agree to abstinence or use effective contraception during the treatment period and for at least 7 months after the last dose of study treatment; 11. Sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1.Receiving anti-tumor therapy in other clinical trials; 2.Received a major surgical procedure unrelated to hepatic cancer within 4 weeks prior to enrollment, or the patient has not fully recovered from such a surgical procedure; 3.Severe cardiac disorder or discomfort, including but not limited to the following conditions: - History of confirmed diagnosis of cardiac failure or systolic dysfunction (LVEF 100 bpm, significant ventricular arrhythmia (such as ventricular tachycardia) or higher grade av block (i.e. av block second degree Mobitz II or atrioventricular block third degree) - angina pectoris requiring antianginal drug therapy - Clinically significant heart valve disorders - ECG showed transmural infarct myocardial - Poor hypertension control (blood pressure systolic > 180 mmHg and/or blood pressure diastolic > 100 mmHg); 4. Autoimmune diseases or other diseases requiring systemic treatment with corticosteroids or immunosuppressive drugs (physiological corticosteroid replacement therapy for adrenal or pituitary insufficiency is allowed); 5. Patients with active brain metastasis; 6. History of primary or acquired immunodeficiency (including allogeneic organ transplant); 7. Female patients who are pregnant or lactating, female patients who are of childbearing potential and have a positive pregnancy test at baseline, or patients of childbearing age who are unwilling to take effective contraceptive measures during the entire trial period and within 7 months after the last study medication; 8. Have a history of pneumonia (non-infectious), or currently have pneumonia requiring steroid therapy; 9. Active or previously documented inflammatory bowel disease (e.g., crohn's disease, colitis ulcerative); 10. Known medical history of the following infection: - Human Immunodeficiency Virus (HIV) - History of acute or chronic hepatitis b or hepatitis c -- Received live viral vaccines within 30 days of planned start of treatment.Seasonal influenza vaccines without live virus are allowed; 11. Patients with known history of allergy to any component of this regimen; with history of immunodeficiency, including positive HIV test, or with other acquired or congenital immunodeficiency diseases, or with history of organ transplantation; 12. Have a serious concurrent disease or other concurrent disease that would interfere with the planned treatment or any other condition that, in the opinion of the investigator, would make the patient unsuitable for participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| progression-free survival, PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective Response Rate, ORR;Duration of Response, DOR;Overall survival, OS;Safety; | — |
Countries
China
Contacts
Public ContactXuan Zhao
The First Affiliated Hospital of Zhengzhou University
Outcome results
None listed