Hepatocellular carcinoma
Conditions
Interventions
Intervention group:In this study, the patient was treated with epalolito volrelimab combined with lenvatinib for 4 cycles before the operation. Adjuvant therapy was initiated 4 weeks after the operati
Repeat every three weeks.
2. Lenvatinib: Oral administration, once daily. Dosage based on body weight: for body weight >=60 kg, 12 mg per day. Weight less than 60 kg, 8 mg per day. Continue to take it
Sponsors
Shanghai Oriental Hepatobiliary Surgery Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Both genders, aged 18 to 75 years. 2. Patients with hepatocellular carcinoma confirmed by histology or pathology, or meeting the clinical diagnostic criteria for hepatocellular carcinoma of the American Association for the Study of Liver Diseases (AASLD). 3. China Liver Cancer Staging (CNLC) stage Ib – IIIa. 4. Child-Pugh class A. 5. Deemed resectable after multidisciplinary team (MDT) evaluation. 6. At least one evaluable lesion per RECIST v1.1. 7. At least one risk factor for tumor recurrence, defined as follows: 1) CNLC stage Ib: solitary tumor diameter >6.5 cm, or 2-3 tumors with maximum diameter 3 cm; 3) CNLC stage IIb: tumor number =12 weeks. 9. No prior antitumor therapy (including radiotherapy, chemotherapy, targeted therapy, immunotherapy, or traditional Chinese medicine) for the current disease. 10. ECOG performance status 0-1. 11. Adequate major organ function, with laboratory tests meeting the following requirements (within 14 days before treatment, no blood transfusion, no granulocyte colony-stimulating factor (G-CSF), and no use of other corrective agents): (1) Complete blood count: absolute neutrophil count (ANC) >=1.5×10^9/L, platelet count (PLT) >=75×10^9/L, hemoglobin (HGB) >=90 g/L; (2) Liver function: total bilirubin (TBIL) =28 g/L; after conventional hepatoprotective therapy, if the above criteria are met and stable for at least 1 week, enrollment may be allowed after investigator's assessment; (3) Renal function: serum creatinine (Cr) =50 mL/min (calculated using the standard Cockcroft-Gault formula); (4) Coagulation function: international normalized ratio (INR) or activated partial thromboplastin time (APTT) =50%. 12. No contraindications for surgery. 13. Subjects agree to use effective contraceptive measures from the signing of the informed consent until 180 days after the last dose. Female of childbearing potential must not be pregnant or breastfeeding. 14. Subjects voluntarily participate in this study, sign the informed consent form, have good compliance, and are willing to cooperate with follow-up.
Exclusion criteria
Exclusion criteria: 1. Prior histologically or pathologically confirmed components of fibrolamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, cholangiocarcinoma, etc. 2. Known previous allergy to macromolecular protein preparations, and contraindication or hypersensitivity to any component of the study drug (e.g., the monoclonal antibody). 3. Other anti-tumor therapies (chemotherapy, radiotherapy, surgery, immunotherapy, biological therapy, chemoembolization, or anti-tumor traditional Chinese medicine therapy). 4. Distant metastasis present on imaging diagnosis. 5. History of allogeneic tissue/solid organ transplantation. 6. Within 2 weeks before the first dose, having a disease requiring systemic corticosteroids (>10 mg daily prednisone or equivalent) or other immunosuppressive drugs (such as cyclophosphamide, azathioprine, methotrexate, thalidomide, TNF-a inhibitors, etc.). Topical corticosteroids, nasal sprays, and inhaled steroids are permitted. Systemic corticosteroids for prevention of contrast allergy are allowed. 7. Active or potentially relapsing autoimmune diseases, except for the following: vitiligo, alopecia, psoriasis, or eczema not requiring systemic treatment; hypothyroidism due to autoimmune thyroiditis requiring only stable-dose hormone replacement therapy; type I diabetes mellitus requiring only stable-dose insulin replacement therapy. 8. Other active malignancies within the past 5 years, except for cured locally treatable cancers (such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix or breast) and breast cancer with no recurrence for >3 years after curative surgery. 9. History of interstitial lung disease and/or pneumonitis, or pulmonary hypertension. 10. Uncontrolled ascites, pericardial effusion, or pleural effusion requiring repeated drainage. 11. Hypertension (systolic blood pressure >150 mmHg and/or diastolic blood pressure >100 mmHg) and diabetes mellitus not well controlled despite standard treatment, and uncontrolled or symptomatic arrhythmias. 12. Thrombotic or embolic events within 6 months before the start of study treatment, such as cerebrovascular accidents (including transient ischemic attack, cerebral hemorrhage, cerebral infarction) or pulmonary embolism. 13. Myocardial infarction, severe/unstable angina, or symptomatic congestive heart failure (NYHA class III or IV) within the past 12 months. 14. Participation in other clinical studies within the past 60 days or during the treatment period. 15. Known active HIV, HBV, or HCV infection. 16. Major surgery (excluding needle biopsy) within 4 weeks before the first dose and not fully recovered. 17. Other conditions that, in the investigator's judgment, make the patient unsuitable for enrollment in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Major Pathological Response Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Recurrence-Free Survival;Incidence of Treatment-Emergent Adverse Events;Objective Response Rate;Incidence of Postoperative Complications;Pathological Complete Response Rate; | — |
Countries
China
Contacts
Public ContactYuan Shengxian,Qiu Jinrong, Zhou Weiping
Shanghai Oriental Hepatobiliary Surgery Hospital
Outcome results
None listed