Unresectable Hepatocellular Carcinoma
Conditions
Interventions
Control Group:TACE/TAE:Subjects in the control group will receive TACE (TAE is permitted if the patient is unwilling to receive chemotherapy).
Experimental Group: TACE/TAE + tislelizumab + lenvatinib:Subjects in the experimental group will additionally receive tislelizumab (intravenous infusion, 200 mg every 3 weeks) combined with lenvatinib
or 8 mg once daily for body weight <60 kg) starting concurrently with the first TACE procedure.
Sponsors
West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Aged 18-75 years, regardless of gender. 2.Diagnosis of HCC must be confirmed by histology or cytology. 3.Disease unsuitable for surgery, transplantation, or ablation but suitable for TACE treatment, including BCLC stage A and B. 4.No evidence of major vascular invasion and/or extrahepatic metastasis. 5.Expected survival >=3 months. 6.Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1. 7.Child-Pugh score A at enrollment. 8.At least one measurable intrahepatic lesion according to RECIST 1.1 criteria. 9.No prior systemic antitumor therapy for HCC. 10.Subjects must have adequate bone marrow and organ function. Laboratory test results within 1 week prior to enrollment must meet the following criteria (without transfusion, granulocyte colony-stimulating factor [G-CSF], or other medical support within 14 days prior to study drug administration): Hemoglobin (Hb) >=90 g/L; Platelet (PLT) count >=75 × 10^9/L; White blood cell (WBC) count >=3.0 × 10^9/L; Absolute neutrophil count (ANC) >=1.5 × 10^9/L; Total bilirubin (TBIL) <=1.5 × upper limit of normal (ULN); Serum creatinine (Cr) <=1.5 × ULN; Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) <=2.5 × ULN 11.Patients voluntarily participate and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1.Patients with a history of or concurrent other malignancies, except cured basal cell carcinoma of the skin or carcinoma in situ of the cervix. 2.Pregnant or lactating patients. 3.Patients with a history of allergic reactions to drugs of the same class. 4.History of interstitial lung disease, non-infectious pneumonitis, or uncontrolled systemic diseases, including diabetes, hypertension, pulmonary fibrosis, acute lung diseases, etc. 5.History of severe cardiovascular diseases within 12 months prior to enrollment, such as symptomatic coronary heart disease, congestive heart failure of Grade II or higher, uncontrolled arrhythmia, myocardial infarction, etc. 6.Any active immunodeficiency or autoimmune disease at screening, and/or a history of any immunodeficiency or autoimmune disease with potential for recurrence (e.g., hypothyroidism or hyperthyroidism, interstitial pneumonia, enteritis, hepatitis, hypophysitis, vasculitis, myocarditis, etc.). 7.History of allogeneic organ transplantation. 8.History of esophageal (gastric fundal) variceal bleeding within 1 month prior to treatment. 9.Use of corticosteroids or other systemic immunosuppressive therapy (at doses >10 mg/day prednisone or equivalent) within 14 days prior to enrollment. 10.Patients with immunodeficiency, such as HIV positivity. 11.History of active hepatitis B or active hepatitis C: Hepatitis B virus (HBV) DNA titer =2000 IU/mL (or 1×10^4 copies/mL), Hepatitis C virus (HCV) RNA above the lower limit of detection. 12.Patients with poorly controlled psychosis. 13.Prior treatment with lenvatinib or other TKI (Tyrosine Kinase Inhibitors), tislelizumab, or other PD-1/PD-L1 inhibitors. 14.Patients with hypertension uncontrolled by antihypertensive medication (systolic blood pressure >160 mmHg, diastolic blood pressure >100 mmHg). 15.Patients with positive urine protein (urine protein test 2+ or higher, or 24-hour urine protein quantitative >1.0 g). 16.Any other condition that, in the investigator's judgment, makes the patient unsuitable for participation in this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-Free Survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival;Objective Response Rate;Disease Control Rate;Duration of Response;Safety; | — |
Countries
China
Contacts
Public ContactYang Biao
West China Hospital, Sichuan University
Outcome results
None listed