Hepatocellular Carcinoma
Conditions
Interventions
experimental group:To receive aiplolitowrelizumab combined with lenvatinib as adjuvant therapy starting 3 to 7 days after TACE sequential thermal ablation.
control group:Adjuvant lenvatinib treatment shall be initiated 3–7 days after sequential thermal ablation subsequent to TACE.
Sponsors
Beijing Youan Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Voluntary participation in the clinical trial; full understanding of and informed consent to the study, as evidenced by the signing of the Informed Consent Form (ICF); willingness and ability to comply with and complete all trial procedures; 2. Aged 18–80 years; gender is not restricted; 3. Histologically or cytologically confirmed HCC, or diagnosed as HCC according to the clinical diagnostic criteria set out in the ‘Diagnosis and Treatment Guidelines for Primary Liver Cancer (2024 Edition)’ issued by the National Health Commission of China; 4. All patients must have undergone TACE followed by radiofrequency ablation (RFA) or microwave ablation (MWA), with the aim of achieving complete ablation of each tumour; 5. Presence of at least one high-risk factor for HCC recurrence: a. Maximum diameter of a single tumour > 5 cm; b. Multiple tumours; 6. All tumours must be free from vascular, bile duct and adjacent organ invasion, as well as distant metastasis; 7. Child-Pugh classification: Grade A; 8. ECOG performance status 0–1; 9. Organ function requirements (laboratory tests within 7 days prior to treatment): 1) Haematology: Absolute neutrophil count (ANC) >= 1.0 × 10?/L; platelet count >= 50 × 10?/L; haemoglobin >= 80 g/L (achieved following transfusion is permitted). 2) Liver function: Total bilirubin =25 g/L. 3) Renal function: Serum creatinine =50 mL/min. 4) Coagulation function: Prothrombin time activity (PTA) >50%. 10. If a subject has HBV or HCV infection, the following criteria must be met: 1) Subjects with HBV infection (HBsAg or HBV-DNA positive): Prior to the first treatment, they must have received guideline-recommended antiviral therapy for at least 3 consecutive days, with follow-up showing a reduction in HBV-DNA, or HBV-DNA < 2000 IU/ml within 4 weeks prior to the first treatment; standard antiviral therapy must be continued throughout the study; 2) Subjects with HCV infection (HCVAb or HCV-RNA positive): If the investigator determines that the subject is in a stable condition (e.g. currently receiving antiviral treatment), treatment must be continued throughout the study; 11. Subjects must use effective contraception for 6 months from the signing of the informed consent form until the end of the final treatment.
Exclusion criteria
Exclusion criteria: 1. Active autoimmune disease, uncontrolled portal hypertension or hepatic encephalopathy; 2. Diagnosis of any other malignancy within 3 years prior to the start of treatment, excluding curatively treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin and/or carcinoma in situ that has been curatively resected; 3. Adverse reactions from prior anticancer therapy that have not yet resolved to a CTCAE 5.0 grade of =2 (excluding toxicities such as alopecia that the investigator deems to pose no safety risk); 4. Known allergy to the study drug or any of its excipients; 5. Severe ascites with significant symptoms, which is not expected to resolve following treatment; 6. Patients with other serious concomitant conditions, such as extensive interstitial pneumonia requiring drug treatment, active or uncontrolled infections (e.g. tuberculosis, HIV), active hepatitis, or active bleeding; patients who have suffered a cerebrovascular accident or pulmonary embolism; patients with active, known or suspected autoimmune diseases; or patients with active infections currently requiring systemic anti-infective therapy; 7. History of histologically or cytologically confirmed hepatocellular carcinoma containing components such as fibrolamellar hepatocellular carcinoma or sarcomatoid hepatocellular carcinoma; 8. History of liver transplantation, organ transplantation or haematopoietic stem cell transplantation; 9. Diseases requiring treatment with systemic corticosteroids (>10 mg/day prednisone or equivalent) or other immunosuppressive agents (such as cyclophosphamide, azathioprine, methotrexate, thalidomide, TNF-a inhibitors, etc.) within 2 weeks prior to the first dose of the study drug or during the study period. 10. Patients with a severe bleeding tendency or coagulation disorders, or those currently undergoing thrombolytic therapy. Patients who have taken non-steroidal anti-inflammatory drugs (e.g. indomethacin, ibuprofen, naproxen, etc.), antiplatelet agents (e.g. clopidogrel, ticlopidine, dipyridamole, cilostazol, etc.) or anticoagulants (e.g. warfarin, low-molecular-weight heparin, etc.) within 10 days prior to the first treatment; 11. The clinician determines that there is a serious non-neoplastic disease, functional impairment or corresponding treatment measures affecting major organs such as the heart, lungs or gastrointestinal tract, including but not limited to: heart disease classified as NYHA Class III–IV, severe/ unstable angina, myocardial infarction within 6 months prior to screening, significant ventricular arrhythmias, severe heart failure, a history of myocarditis or test results suggestive of myocarditis, poorly controlled hypertension (systolic blood pressure >=160 mmHg or diastolic blood pressure >=100 mmHg), severe respiratory depression with hypoxia and/or hypercapnia, severe chronic obstructive pulmonary disease, cor pulmonale, severe bronchial asthma, severe viral infections and septic shock, severe diabetes, immune-related diseases, haematological disorders, or a history of major surgery; 12. Major vascular disease (e.g. abdominal aortic aneurysm) within 6 months prior to the first treatment; 13. Psychiatric disorders, drug or alcohol abuse; 14. Having received or planning to receive live or attenuated vaccines within 4 weeks prior to the first dose of the investigational drug, or during the study period, excluding inactivated seasonal influenza vaccines; 15. Pregnant or breastfeeding subjects; 16. Participati
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1-year RFS rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| 1-Year Extrahepatic Metastasis Rate;1-Year Intrahepatic Recurrence Rate;Relapse free survival, RFS;1-Year and 2-Year Survival Rates; | — |
Countries
China
Contacts
Public ContactLi Jianjun
Beijing Youan Hospital, Capital Medical University
Outcome results
None listed