hepatocellular carcinoma
Conditions
Interventions
experimental group:Adbelimumab + bevacizumab
Sponsors
The First Affiliated Hospital of Nanjing Medical University (Jiangsu Province Hospital)
Eligibility
Sex/Gender
All
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Voluntarily participate in this study and sign informed consent; 2. Age 18-100 years old, male or female; 3. Hepatocellular carcinoma confirmed by histopathology, cytology, or imaging; 4. CNLC stage I-II; 5. After surgical resection or local ablation, no residual margin was found by intraoperative pathology, or CR was confirmed by imaging within 4-8 weeks after surgery; 6. Have at least one high-risk factor for recurrence: (Definition of high-risk recurrence factors: after radical surgery: the presence of a single tumor diameter > 5 cm; Tumor number =3; Combined with vascular invasion (microvascular invasion or Vp1-2); Tumor grade III-IV; After ablation: 1. Single tumor >2cm but = 5cm; 2. Multiple tumors: 2-4, all tumors =5 cm); 7. ECOG PS score: 0-1; 8. Child-Pugh liver function: grade A (=6) 9. Expected survival time =12 months; 10. Laboratory test results within 3 days before the first dose of medication meet the following requirements: (1) Blood routine examination: (except hemoglobin, no blood transfusion, no G-CSF, and no medication correction within 2 weeks before screening) : ? Absolute neutrophil count =1.5×109/L; ? Platelet =75×109/L; ? hemoglobin =90 g/L; (2) Biochemical examination: ? Serum albumin =30g/L; ? Serum total bilirubin =1.5×ULN; ?ALT and AST =3×ULN; ? Serum creatinine =1.5×ULN; Or Cr clearance > 50 mL/min (3) International normalized ratio (INR) =1.2 or prothrombin time (PT) beyond the normal range =2 seconds; (4) urinary protein <2+ (if urinary protein =2+, 24-hour urinary protein quantification could be performed, and 24-hour urinary protein quantification <1.0g could be enrolled); 11. If you have hepatitis B virus (HBV) infection, HBV-DNA should be tested, and HBV-DNA should be <2000 IU/mL (<104 copy/mL if the research center has only copy/mL testing unit); Participants with HBV-DNA=2000 IU/mL received antiviral therapy (only nucleoside drugs such as entecavir, tenofovir dipivoxil fumarate, and tenofovir propofol fumarate tablets) for at least 1 week before the first dose and had a viral copy number decrease of more than 10-fold (1 lg) from the baseline. For patients with HBV infection, antiviral therapy should be received throughout the study period. Hepatitis C virus (HCV) -RNA positive subjects must receive antiviral therapy according to treatment guidelines. 12. Women of childbearing age must have a negative pregnancy test (ßHCG) before starting the first dose of medication. Women of reproductive age and men (who have sex with a woman of reproductive age) must agree to contraception during treatment and within 6 months of the last dose.
Exclusion criteria
Exclusion criteria: 1. Known fibrolamellar HCC, sarcomatoid HCC or mixed cholangiocarcinoma and HCC; 2. Evidence of residual, recurrent, or metastatic disease; 3. History of hepatic encephalopathy; 4. Prior allogeneic stem cell or solid organ transplantation or on the waiting list for liver transplantation; 5. Any treatment prior to resection or ablation of hepatocellular carcinoma, including systemic therapy (including investigational agents) and local therapy such as TACE; And patients who received more than one cycle of adjuvant TACE after surgical resection; 6. History of a malignancy other than HCC within 5 years before the index dose, except for malignancies with a negligible risk of metastasis or death (e.g., 5-year OS rate >90%), such as adequately treated cervical carcinoma in situ, nonmelanoma skin cancer, localized prostate cancer, ductal carcinoma in situ, or stage I uterine cancer; 7. Co-infection of HBV and HCV, co-infection of HBV and hepatitis D virus; 8. A history of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonia, or idiopathic pneumonia, or evidence of active pneumonia on chest CT scan at screening; 9. Active tuberculosis; 10. A history of autoimmune disease or immunodeficiency, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid antibody syndrome, Wegener's granulomatosis, Sjogren's syndrome, Guillain-Barre syndrome, or multiple sclerosis; 11. Severe infection within 4 weeks before the first dose of medication, including but not limited to hospitalization for infectious complications, bacteremia, or severe pneumonia; 12. Oral or intravenous antibiotic therapy within 2 weeks before the first dose; 13. Use of non-steroidal anti-inflammatory drugs (nsaids) for daily treatment of chronic diseases; 14. Bleeding diathesis or significant evidence of coagulopathy (without anticoagulant therapy); 15. Current or recent use of aspirin or full-dose oral or intravenous anticoagulants; 16. Bleeding events due to untreated or incompletely treated esophageal and/or gastric varices within 6 months before the first dose of medication; 17. Major vascular disease (e.g., aortic aneurysm requiring surgical repair or recent peripheral artery thrombosis) within 6 months before the first dose of medication; 18. Inadequately controlled arterial hypertension (systolic blood pressure, =140 mmHg or diastolic blood pressure, =90 mmHg) (based on the mean of =2 readings), allowing the use of antihypertensive treatment to achieve these parameters; A history of hypertensive crisis or hypertensive encephalopathy; 19. Significant uncontrolled or symptomatic hypercalcemia (ionized calcium >1.5 mmol/L, calcium >12 mg/dL, or corrected serum calcium >ULN) before the first dose of medication; 20. Severe cardiovascular disease (e.g., New York Heart Association class II or higher heart disease, myocardial infarction, or cerebrovascular accident), unstable arrhythmia, or unstable angina within 3 months; 21. Clinically significant ascites; 22. A history of intra-abdominal inflammation, including but not limited to peptic ulcer, diverticulitis, or colitis, within 6 months before the first dose of medication; 23. History of abdominal or tracheoesophageal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months before the first medication; 24. Severe, no
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Recurrence-free survival at 1 year; | — |
Secondary
| Measure | Time frame |
|---|---|
| 6 months disease-free survival;Recurrence-free survival;Time to recurrence; | — |
Countries
China
Contacts
Public ContactXiangcheng Li
The First Affiliated Hospital of Nanjing Medical University (Jiangsu Province Hospital)
Outcome results
None listed