hepatocellular carcinoma
Conditions
Interventions
experimenttal group A:TACE+Tislelizumab
experimenttal group B:TACE+Tislelizumab
experimenttal group C:TACE+Tislelizumab +pegylated interferon alpha-2a
Sponsors
The First Affiliated Hospital of Anhui Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Patients are voluntary and able to provide written informed consent for the study and consent to donate tissue to a tissue repository. 2. Aged 18-75 years at the time of signing the written informed consent, regardless of gender. 3. HCC is diagnosed based on AASLD imaging standards or cytology/histology. 4. HCC is technically resectable and can be completely resected at the end of surgery by adding +/- intraoperative radiofrequency ablation (RFA), with no evidence of extrahepatic metastasis, lymph nodes 40% liver residue , 2 cm. 5. Liver biopsy pathological results meeting the following criteria: GSDMB+ >10%, CD3+ >1%, CD3+PD-1+ >0% or GSDMB+ 1%, CD3+PD- 1+ >0%. 6. Blood routine (no blood transfusion, G-CSF, or medication intervention within 14 days before screening): neutrophil count =1.2 × 10^9/L, platelet count =80 × 10^9/L, hemoglobin =9 g/dL or =5.6 mmol/L. 7. Serum biochemistry (no intravenous infusion of albumin within 14 days before screening): serum creatinine =1.5 ULN or creatinine >60 mL/min for patients with creatinine >1.5 ULN, total bilirubin =2 ULN , AST (SGOT) and ALT (SGPT) =2.5 ULN, albumin =3.0 g/dL. 8. Coagulation function: INR or PT and APTT =1.5 ULN , or within the range recommended for anticoagulant therapy in patients with thrombotic events. If necessary, these abnormalities can be corrected according to the actual situation at the time of liver resection. 9. Child-Pugh score =6. 10. Scheduled to undergo liver resection within 5-6 weeks. 11. Fertile female subjects should have pregnance-negative urine or serum within 72 hours before receiving the first dose of the study drug. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test is required. 12. Fertile female or male subjects must consent to the use of an appropriate contraceptive method during the study period and for 120 days after the last dose of the study drug. 13. ECOG performance status =1. 14. If the subject has hepatitis B virus (HBV) infection: if HBsAg is positive, HBV-DNA should be tested and the HBV-DNA should be <2000 IU/mL (or <10^4 copies/mL if IU/mL is used as the only detection unit) and agree to receive antiviral therapy throughout the study period if HBSAg is positive; subjects infected with hepatitis C virus (HCV) and HCV RNA should be <1 × 10^3 copies/mL and must receive antiviral therapy according to treatment guidelines.
Exclusion criteria
Exclusion criteria: 1. The image shows the presence of distant metastasis; 2. Those who have previously received other anti-tumor treatment options (including surgery, radiotherapy, systemic therapy, etc.), except those who were cured by liver resection and/or RFA at least 24 months before the current HCC diagnosis; 3. Patients who have allergic reactions to similar drugs in the past; 4. Patients who have previously received organ transplants; 5. Pregnant or lactating patients; 6. There is pericardial effusion, uncontrolled pleural effusion, or clinically severe ascites at the time of screening (including ascites detected in the physical examination at the time of screening or ascites requiring puncture extraction); 7. There has been untreated esophageal or gastric varicose bleeding within the last 6 months; 8. Patients accompanied by interstitial lung disease, non-infectious pneumonia or uncontrollable systemic disease history, including diabetes, hypertension, pulmonary fibrosis, acute lung disease; 9. Patients who have severe cardiovascular disease, such as symptomatic coronary heart disease, = grade II congestive heart failure, uncontrolled arrhythmia, or myocardial infarction in the 12 months prior to enrollment; 10. Patients who have any active immune deficiency or autoimmune disease at the time of screening and/or a history of any immune deficiency or autoimmune disease that may recur (e.g. hypothyroidism or hyperthyroidism, interstitial pneumonia, enteritis, hepatitis, pituitaritis, vasculitis, myocarditis, etc.) at screening period; Steroids or other systemic immunosuppressive therapy were used for the first 14 days of enrollment 11. Patients with other malignant tumors that have not been cured; 12. Patients with immune deficiencies, such as HIV positive; 13. Patients with uncontrollable mental illness; 14. There is an active infection that requires systemic treatment; 15. Received interferon antiviral therapy within 4 weeks before enrollment; 16. Live vaccine was administered within 30 days before the first administration of the study drug; 17. Major surgery on any site in the 4 weeks prior to first taking the study drug; 18. Minor surgery was performed=7 days before the first dose of the study drug; 19. Dual active HBV infection [HBsAg (+) and/or detectable HBV DNA] and HCV infection [anti-HCV Ab (+) and detectable HCV RNA] at the time of screening; 20. Other factors led the investigator to believe that the patient should not participate in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| MPR rate;Single cell tests (transcriptome, VDJ, and spatial transcriptome) were performed on tumor specimens to reveal changes in the immune microenvironment ; | — |
Secondary
| Measure | Time frame |
|---|---|
| Reduction rate of Biomarkers;Objective response rate;R0 rate;Adverse events; | — |
Countries
China
Contacts
Public ContactBeicheng Sun
The First Affiliated Hospital of Anhui Medical University
Outcome results
None listed