Hepatocellular carcinoma
Conditions
Interventions
Intervention group:Aetology combination antibody (Epalrotolitowenli, PD-1/CTLA-4 bispecific antibody) 7.5 mg/kg intravenous infusion every 3 weeks
lenvatinib 8 mg/day orally. Patients receive conversion therapy with tumor response (mRECIST criteria) and surgical feasibility assessed every 3 months
those meeting conversion criteria undergo curative resection
postoperative individualized adjuvant therapy is determined based on pathological response.
Sponsors
Affiliated hangzhou first people's hospital, zhejiang university school of medicine
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Sign a written informed consent form and be able to comply with the scheduled visits and related procedures as specified in the protocol. 2. Age >=18 years and =12 weeks. 11. No prior systemic therapy. 12. Female subjects of childbearing potential or male subjects with female partners of childbearing potential must use effective contraception during the entire treatment period and for 6 months after the end of treatment. 13. Have adequate organ and bone marrow function, with laboratory values within the following criteria within 7 days prior to enrollment (no administration of any blood components, cell growth factors, albumin, or other corrective medications within 14 days prior to laboratory tests): Hematology: Absolute neutrophil count (ANC) >=1.5×10^9/L; platelet count (PLT) >=50×10^9/L; hemoglobin (HGB) >=8.5g/dL. Liver function: Serum total bilirubin (TBIL) =28g/L; alkaline phosphatase (ALP) =50mL/min (Cockcroft-Gault formula); urinalysis shows urine protein <2+. Coagulation function: International normalized ratio (INR) <=2 and activated partial thromboplastin time (APTT) <=1.5×ULN.
Exclusion criteria
Exclusion criteria: 1.History of hepatic encephalopathy or history of liver transplantation. 2.Presence of clinically symptomatic or drainable pleural effusion, ascites, or pericardial effusion. Patients with only imaging evidence of minimal effusion and without related symptoms may be enrolled. 3.Chronic hepatitis C virus infection. 4.Symptomatic central nervous system metastases. However, patients with asymptomatic brain metastases or stable symptoms after treatment may be included if all of the following criteria are met: measurable lesions outside the central nervous system; no metastasis involving the midbrain, pons, cerebellum, meninges, medulla oblongata, or spinal cord; stable clinical status for at least four weeks; discontinued corticosteroids at least two weeks prior to the first dose of the investigational drug. 5.Esophageal or gastric variceal bleeding due to portal hypertension within the previous 6 months. Patients with evidence of portal hypertension (including radiographic splenomegaly) must undergo endoscopic evaluation within 3 months; those with severe varices cannot be enrolled. 6.Any life-threatening bleeding event within the prior 3 months, including those requiring transfusion, surgery, local intervention, or ongoing medication. 7.Arterial or venous thromboembolic events (including myocardial infarction, unstable angina, cerebrovascular accident or transient ischemic attack, pulmonary embolism, deep vein thrombosis, or other serious thromboembolic events) within the previous 6 months. Thrombosis related to venous access devices or superficial veins, if stable after conventional anticoagulation, are not excluded. Prophylactic use of low-dose aspirin or low molecular weight heparin is allowed. 8.Uncontrolled hypertension: systolic blood pressure =150 mmHg or diastolic pressure =100 mmHg following optimal medical management; history of hypertensive crisis or hypertensive encephalopathy. 9.Symptomatic congestive heart failure (NYHA class II–IV), symptomatic or poorly controlled arrhythmias, or prolonged QT interval (QTc >450 ms in males, QTc >470 ms in females). 10.Severe bleeding tendency or coagulation disorders, or receiving thrombolytic therapy. 11.History of gastrointestinal perforation and/or fistula, intestinal obstruction (including sub-occlusion requiring parenteral nutrition), inflammatory bowel disease, extensive bowel resection (partial colectomy or extensive small bowel resection with chronic diarrhea), Crohn’s disease, ulcerative colitis, or chronic diarrhea, within the past 6 months. 12.History of interstitial lung disease, drug-induced pneumonitis, idiopathic pulmonary fibrosis, or active pneumonitis. Radiotherapy-induced pneumonitis restricted to the radiation field is allowed. 13.Active pulmonary tuberculosis (TB); patients currently receiving anti-tuberculosis therapy or who have received anti-tuberculosis treatment within 1 year prior to the first administration of study drug. 14.HIV infection (positive for HIV-1/2 antibodies). 15.Active or poorly controlled severe infection, including, but not limited to, hospitalization for infection, bacteremia, or severe pneumonia within 4 weeks prior to first dose of study drug. 16.Active systemic autoimmune disease or history of autoimmune disease within the past 2 years that requires systemic therapy (patients with vitiligo, psoriasis, alopecia, or Graves’ disease not requiring systemic therapy in the past 2 years, hypothyroidism requiring only thyroid hormone r
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Conversion rate;; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate;Recurrence-free survival rate;Disease control rate;Overall survival time; | — |
Countries
China
Contacts
Public ContactZhou Lixin
Affiliated hangzhou first people's hospital, zhejiang university school of medicine
Outcome results
None listed