Hepatocellular Carcinoma
Conditions
Interventions
The combined treatment group of Iparomlimab/Tuvonralimab and lenvatinib:The subjects received treatment withIparomlimab/Tuvonralimab (7.5 mg/kg, IV, D1, Q3W) + lenvatinib (8 mg for body weight =60 kg,
Sponsors
West China Hospital of Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Subjects must meet all of the following inclusion criteria to be eligible for this trial: 1. Voluntarily participate in the study, sign the Informed Consent Form (ICF), demonstrate good compliance, and cooperate with follow-up visits. 2. Subjects must be between 18 and 75 years of age, regardless of gender. 3. Histologically, cytologically, or clinically confirmed hepatocellular carcinoma (per the Guidelines for Diagnosis and Treatment of Primary Liver Cancer [2024 Edition]). For patients with cytologically or histologically confirmed HCC, provision of tumor tissue samples for testing is recommended. 4. No prior systemic antitumor therapy for hepatocellular carcinoma (including but not limited to molecular targeted therapy, systemic chemotherapy, anti-PD-1/PD-L1/CTLA-4 immunotherapy, etc.) has been received. 5. Barcelona Clinic Liver Cancer (BCLC) stage C, or stage B not amenable to curative surgery and/or local treatment. 6. According to RECIST v1.1, the subject must have at least one measurable target lesion confirmed by imaging during the screening period. The measurable lesion should not have undergone prior local treatment such as radiotherapy (however, lesions located within a previously treated area may still be selected as target lesions if progression is confirmed). 7. Child-Pugh liver function class A or B (score =12 weeks; 10. For subjects with hepatitis B virus (HBV) infection: If HBsAg-positive, HBV-DNA must be tested and confirmed as =90 g/L; b) ANC >=1.5×10?/L; c) PLT >=75×10?/L. Biochemical tests: ALB >=29 g/L; ALT and AST =50 mL/min; INR =2+, a 24-hour urine protein quantification can be performed; subjects with <1.0 g/24h are eligible). 12. For women of childbearing potential : Must agree to either abstain from heterosexual intercourse or use reliable, effective contraception from the time of signing the informed consent until at least 120 days after the last dose of study treatment. A negative serum pregnancy test (HCG) must be confirmed within 72 hours prior to study intervention. Must not be breastfeeding. 13. For male subjects with female partners of childbearing potential: Must agree to either abstain from heterosexual intercourse or use reliable, effective contraception from the time of signing the informed consent until at least 120 days after the last dose of study treatment. Must also agree not to donate sperm during this period. Male subjects with pregnant partners must use condoms; no additional contraception is required.
Exclusion criteria
Exclusion criteria: Exclusion Criteria: Subjects who meet any of the following conditions will not be included in the study: 1. Histologically or cytologically confirmed fibrolamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, intrahepatic cholangiocarcinoma, mixed-type hepatocellular carcinoma, etc.; 2. Tumor thrombus involving both the main portal vein and its left/right branches, or tumor thrombus involving both the main portal vein and the superior mesenteric vein, or tumor thrombus involving both the hepatic vein and the inferior vena cava; 3. History of or concurrent active malignancies other than HCC within the past 5 years; 4. History of liver transplantation or planned liver transplantation. 5. Clinically symptomatic moderate or severe ascites requiring therapeutic paracentesis or drainage (excluding cases with only minimal ascites on imaging and no clinical symptoms), or uncontrolled or moderate-to-large pleural effusion, pericardial effusion, etc.; 6. Significant clinically relevant bleeding symptoms within the past 6 months before study intervention or a clear bleeding tendency, such as gastrointestinal bleeding, severe esophageal/gastric varices, hemorrhagic gastric ulcers, or vasculitis. If baseline fecal occult blood test is positive, a repeat test is required; if still positive, gastroscopy must be performed. 7. Poorly controlled cardiac clinical symptoms or diseases, including: 1) Cardiac insufficiency classified as NYHA (New York Heart Association) Class II or higher, or left ventricular ejection fraction (LVEF) 450 ms (male) or >470 ms (female) on resting electrocardiogram (ECG). 8. Arterial thromboembolic events within the past 6 months before study intervention, such as cerebrovascular accidents (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), CTCAE Grade 3 or higher deep vein thrombosis, pulmonary embolism, etc.; 9. Hypertension that cannot be adequately controlled with antihypertensive medication (systolic blood pressure >=140 mmHg or diastolic blood pressure >=90 mmHg; based on the average of >=2 BP measurements). Antihypertensive therapy is permitted to achieve these parameters; history of hypertensive crisis or hypertensive encephalopathy; 10. Major surgical procedures (excluding diagnostic procedures) within 4 weeks before study intervention or anticipated requirement for major surgery during the study period; 11. Severe, non-healing, or dehiscing wounds, active ulcers, or untreated fractures; 12. Significant vascular disease (e.g., aortic aneurysm requiring surgical repair or recent peripheral arterial thrombosis) within the past 6 months before study intervention; 13. Known hereditary or acquired bleeding (e.g., coagulation disorders) or thrombotic tendencies, such as hemophilia, clotting dysfunction, thrombocytopenia, etc.; current therapeutic use of full-dose oral or injectable anticoagulants or thrombolytic agents (prophylactic use of low-dose aspirin, etc., is permitted). 14. Current interstitial pneumonia or interstitial lung disease, or a history of interstitial pneumonia/interstitial lung disease requiring corticosteroid treatment; or other conditions that may interfere with the assessment and management of immune-relat
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| overall response reate (ORR) (RECIST v1.1); | — |
Secondary
| Measure | Time frame |
|---|---|
| overall response reate (ORR) (mRECIST );Overall survival ;Adverse events; | — |
Countries
China
Contacts
Public ContactHong Wu
West China Hospital of Sichuan University
Outcome results
None listed