Hepatocellular carcinoma
Conditions
Interventions
experimental group:Surgery after neoadjuvant therapy
control group:Direct surgery
Sponsors
West China Hospital of Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-70 years, gender is not limited; 2. HCC subjects confirmed by the clinical diagnostic criteria of the "Guidelines for the Diagnosis and Treatment of Primary Liver Cancer"(2019 edition) or confirmed by histopathological or cytological examinations; 3. Have not received any systemic therapy for HCC in the past; 4. ECOG PS score 0-1; 5. Child-Pugh liver function classification is grade A; 6. Chinese liver cancer subjects with stage IIb or IIIa liver cancer, namely BCLC stage B and C liver cancer subjects; and the tumor is resectable; 7. According to the Response Evaluation Criteria for Solid Tumors (mRECIST), there is at least one measurable lesion on imaging; 8. If HBsAg positive subjects, HBV-DNA < 200000 IU/ml (106 copies/ml), conventional antiviral therapy; 9. The main organs are functioning normally, that is, the following criteria are met: (1) Adequate bone marrow function, defined as: absolute neutrophil count (ANC greater than or equal to 1.5 x 10^9 per liter (/L), hemoglobin (Hb greater than or equal to 8.5 grams per deciliter (g/dL)), platelet count greater than or equal to 75x10^9/L; (2) Good liver function, defined as: aspartate aminotransferase (AST), alkaline phosphatase (ALP) and alanine aminotransferase (ALT) less than or equal to 5 ULN; (3) Good coagulation function, defined as an international normalized ratio (INR) less than or equal to 2.3; (4) Adequate renal function, defined as a creatinine clearance greater than 40 milliliters per minute (mL/min), calculated according to the Cockcroft and Gault formula; (5) Adequate pancreatic function, defined as amylase and lipase <= 1.5 x ULN; (6) Normal thyroid function, defined as thyroid-stimulating hormone (TSH) within the normal range. If the baseline TSH exceeds the normal range, subjects with total T3 (or FT3) and FT4 within the normal range can also be enrolled; 10. Adequate blood pressure (BP) control with up to 3 antihypertensive drugs, defined as BP <= 150/90 mmHg at screening, and no change in antihypertensive therapy within 1 week prior to Cycle 1/Day 1; 11. The subject is expected to survive for more than 3 months; 12. No pregnancy or pregnancy plans; 13. The subjects voluntarily joined the study, signed the informed consent form, had good compliance, and cooperated with the follow-up.
Exclusion criteria
Exclusion criteria: 1. Extrahepatic metastasis of primary liver cancer; 2. Diffuse liver cancer, intrahepatic tumor burden >= 50% of liver volume; or/and portal vein tumor thrombus was classified as type IV; or/and inferior vena cava tumor thrombus; 3. Contraindications of TACE and epirubicin; 4. Those who have participated in other clinical trial drugs within 4 weeks; 5. Those who are known to be allergic to tislelizumab components; 6. Patients with myocardial ischemia or myocardial infarction above grade II, and poorly controlled arrhythmias (including QTc interval >= 470 ms); according to the NYHA standard, grade III-IV cardiac insufficiency, or left ventricular ejection fraction (LVEF < 50%) indicated by echocardiography; 7. Have a history of mental illness or abuse of psychotropic substances; 8. Combined with HIV-infected patients; 9. Known allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation; 10. Patients with active infection.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1-year recurrence-free survival; | — |
Countries
China
Contacts
Public ContactPeng Wei
West China Hospital of Sichuan University
Outcome results
None listed