Resectable Hepatocellular Carcinoma
Conditions
Interventions
Triple neoadjuvant therapy group:Transcatheter Arterial Chemoembolization Combined with Lenvatinib plus Cadonilimab
Sponsors
Fujian Provincial Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Voluntarily join the study and sign the informed consent form; 2.Male or female patients aged between 18 and 75 years; 3.Child-Pugh class A; 4.Indocyanine green 15-minute retention rate (ICGR-15) = 10 mm on CT/MRI scan, and the measurable lesion has not received local treatments such as radiotherapy or cryotherapy); 9.Blood routine: absolute neutrophil count >= 1.5 × 10^9/L, Hb >= 8.5 g/L, PLT >= 75 × 10^9/L; 10.No history of severe arrhythmia, heart failure, severe pulmonary ventilation disorders, or severe lung infections; no acute or chronic renal failure, and creatinine clearance rate > 40 mL/min; 11.Women of childbearing potential must agree to use contraception during the medication period and for 6 months after the end of medication; have a negative serum or urine pregnancy test within 7 days prior to enrollment, and must not be breastfeeding. Men must agree to use contraception during the study period and for 6 months after the end of the study.
Exclusion criteria
Exclusion criteria: 1.Tumor rupture with bleeding or suspected abdominal cavity metastasis; 2.Previous treatment with any antitumor therapies before enrollment, such as targeted drugs, PD-1/PD-L1/CTLA-4 monoclonal antibodies, surgery, TACE, FOLFOX systemic chemotherapy, radiotherapy, and Huaier granules; 3.History of allergy to lenvatinib, cadonilimab, or their components; 4.Presence of any active autoimmune disease or a history of autoimmune disease with expected recurrence (e.g., interstitial pneumonia, colitis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism, including but not limited to these diseases and syndromes); hypothyroidism treated with stable doses of thyroid replacement hormone; type 1 diabetes mellitus treated with stable doses of insulin; excluding patients with vitiligo or childhood asthma/allergies that have resolved and require no intervention in adulthood; 5.History of immunodeficiency; patients using immunosuppressive drugs or systemic corticosteroids for immunosuppressive purposes and who have continued using them within 2 weeks before signing the informed consent form; 6.Known hereditary or acquired bleeding (e.g., coagulopathy) or thrombotic tendency, such as hemophilia; currently receiving or recently (within 10 days before the start of study treatment) receiving full-dose oral or injectable anticoagulants or thrombolytics for therapeutic purposes (prophylactic use of low-dose aspirin and low-molecular-weight heparin is allowed); 7.Severe infection within 4 weeks before the first use of the study drug (CTC AE grade > 2), such as severe pneumonia requiring hospitalization, bacteremia, or infection complications; baseline chest imaging indicating active lung inflammation; symptoms and signs of infection within 2 weeks before the first use of the study drug or requiring oral or intravenous antibiotic treatment (excluding prophylactic antibiotic use); 8.Urinalysis indicating proteinuria >= 1+; if so, a 24-hour urine protein test is required; patients with 24-hour urine protein >= 1 g; 9.History of other malignancies within the past 5 years or concurrently, except for cured basal cell carcinoma of the skin, cervical carcinoma in situ, and papillary thyroid carcinoma; 10.Patients with concomitant psychiatric disorders; history of substance abuse, alcohol, or drug addiction; 11.Pregnant or breastfeeding women; 12.Patients with significant surgical contraindications, such as renal and cardiopulmonary insufficiency, as judged by the investigator, or any other reasons deemed unsuitable for participation in this trial by the investigator;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Major pathological response rate;Surgical mortality rate;Incidence of adverse reactions;Incidence of surgical complications;Reoperation rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate;Recurrence-free survival;R0 resection rate;Overall survival; | — |
Countries
China
Contacts
Public ContactYan Maolin
Fujian Provincial Hospital
Outcome results
None listed