Unresectable Hepatocellular Carcinoma
Conditions
Interventions
Treatment Group:Iparomlimab and Tuvonralimab Injection in combination with TACE/HAIC and Lenvatinib
Sponsors
West China Hospital of Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Aged 18–75 years old; 2.Confirmed diagnosis of hepatocellular carcinoma (HCC) by imaging, histology, or cytology, in accordance with the criteria of the American Association for the Study of Liver Diseases (AASLD); 3.BCLC stage B or C unresectable HCC patients, including those with portal vein tumor thrombus (PVTT) classified as VP1–3. Patients with complete occlusion of the main portal vein by tumor thrombus (without detectable blood flow) are excluded; 4.At least one measurable lesion according to the RECIST v1.1 criteria: non-lymph node lesions with longest diameter >=10 mm, or lymph node lesions with shortest diameter >= 15 mm on CT scan; 5.No prior history of systemic anti-tumor therapy, including but not limited to immunotherapy, targeted therapy, anti-tumor traditional Chinese medicine therapy, etc; 6.ECOG performance status score of 0–1; 7.Child-Pugh score == 1.5 × 10^9/L?Platelet (PLT) count >=70×10^9/L?Hemoglobin (HGB) >= 90 g/L;b. Liver function: Total bilirubin (TBIL) == 28 g/L; Alkaline phosphatase (ALP) == 50 mL/min;d. Coagulation function: International normalized ratio (INR) =< 1.5 or prothrombin time (PT) =< 1.5 × ULN; activated partial thromboplastin time (aPTT) =< 1.5 × ULN. For patients receiving anticoagulant therapy, those with PT and INR within the specified range of the anticoagulant are eligible; 9.Expected survival of at least 3 months;
Exclusion criteria
Exclusion criteria: 1.Fibrolamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, cholangiocarcinoma, and other malignancies confirmed by prior histology/cytology; 2.HCC patients ineligible for local therapy; 3.Concurrent other malignant tumors or a history of other malignancies; 4.Prior history of systemic anti-tumor therapy; 5.Tumor burden exceeding 70% of the total liver volume; 6.Candidates for liver transplantation or a history of liver transplantation; 7.Current presence of bleeding, coagulation dysfunction, or risk of thrombolytic therapy or a history of esophageal or gastric variceal bleeding within 6 months prior to enrollment; 8.Main portal vein tumor thrombus (PVTT Vp4); 9.Known hypersensitivity to macromolecular protein preparations or any components of the study drugs; 10.Active autoimmune disease or a history thereof, including but not limited to autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hypoadrenocorticism, vasculitis, nephritis; thyroid dysfunction (hyperthyroidism/hypothyroidism) that cannot be maintained within the normal range by medication, or a history of thyroid surgery requiring long-term thyroid hormone replacement therapy. Patients with vitiligo or childhood asthma that resolved completely in adulthood without any intervention may be enrolled, while asthma patients requiring medical intervention with bronchodilators are excluded. 11.Patients currently receiving immunosuppressants, or systemic or absorbable topical corticosteroid therapy for immunosuppressive purposes (prednisone > 10 mg/day or equivalent), and who continued such treatment within 2 weeks prior to enrollment; 12.Use of traditional Chinese medicine or other immunomodulators within 2 weeks prior to enrollment; 13.Symptomatic ascites or pleural effusion uncontrolled by medication, requiring therapeutic paracentesis or drainage; 14.Poorly controlled clinical symptoms or cardiac diseases, such as heart failure >= NYHA Class II, unstable angina, myocardial infarction within 1 year, clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention; 15.Active or poorly controlled severe infection. Severe infection within 4 weeks prior to the first dose, including but not limited to hospitalization due to infectious complications, bacteremia, or severe pneumonia; or unexplained fever > 38.5°C during screening and before the first dose (patients may be enrolled for tumor-related fever at the investigator’s discretion); 16.Objective evidence of past or present pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-related pneumonitis, severely impaired pulmonary function; known syphilis infection requiring treatment; active tuberculosis (TB) currently receiving anti-TB therapy, or having received anti-TB therapy within 1 year prior to the first dose; 17.Congenital or acquired immunodeficiency, such as human immunodeficiency virus (HIV) infection, or active hepatitis (transaminases not meeting inclusion criteria: Hepatitis B: HBV DNA >= 2000 IU/mL or >= 10^4 copies/mL; Hepatitis C: HCV RNA >= 2000 IU/mL or >= 10^4 copies/mL. Patients with viral load below the above thresholds after nucleoside analogue antiviral therapy are eligible. Chronic hepatitis B carriers with HBV DNA < 10^4 IU/mL are eligible, provided they receive antiviral therapy throughout the study; 18.Vaccination with a live vaccine during the study or within 4 weeks prior to enrollment;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate,ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease control rate, DCR;PFS;Overall survival, OS;The incidence of AE; | — |
Countries
China
Contacts
Public ContactChang liu
West China Hospital of Sichuan University
Outcome results
None listed