hepatocellular carcinoma
Conditions
Interventions
Surgical group:Hepatectomy
Neoadjuvant therapy group:Lenvatinib +Tislelizumab+ Transcatheter arterial chemoembolization
Sponsors
Fujian Provincial Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age =18 years and =75 years. 2. The clinical or pathological diagnosis was consistent with primary HCC. 3. Stage A BCLC, single tumour, > 5cm in diameter and tumour can be resected entirely; 4. Adequate residual liver volume. With cirrhosis, the residual liver volume was more than 40%. No cirrhosis, residual liver volume more than 30%; 5. According to the mRECIST criteria, the patient had at least one measurable lesion (CT scan diameter =10mm, and the quantifiable lesion had not received local treatment such as TACE, radiotherapy, radiofrequency, or freezing). 6. ECOG score: 0-1; Child-PughA liver function. 7. Blood routine: absolute neutrophil count =1.5×10^9/L, Hb=8.5g/L, PLT=75×10^9/L. 8. No history of severe arrhythmia or heart failure; No history of severe ventilatory dysfunction or severe pulmonary infection; No acute or chronic renal failure; creatinine clearance >40mL/min. 9. The expected survival time is more significant than three months.
Exclusion criteria
Exclusion criteria: 1. BCLC stage A patients with multiple tumours, or BCLC stage B, C, and D patients. 2. Other antitumor therapies have been used, such as targeted drugs, PD-1, other immunotherapy, surgery, TACE, FOLFOX systemic chemotherapy, and Xiaoer granule drug therapy. 3. Allergic history of lenvatinib and tislelizumab ingredients or excipients. 4. Patients with any active autoimmune or autoimmune disease with expected recurrence. 5. The patient uses immunosuppressive agents or systemic hormone therapy to achieve immunosuppression. 6. Patients with proteinuria indicated by urine routine =1 + will be tested for 24-hour proteinuria, and patients with 24-hour proteinuria =1g. 7. Patients with other malignant tumours. 8. Co-existing with mental illness. 9. Pregnant or lactating women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1-year recurrence-free survival rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| R0 resection rate;Overall survival;Objective response rate;Operation delay rate;Major pathological response;Safety;2-year recurrence-free survival rate; | — |
Countries
China
Contacts
Public ContactYan Maolin
Shengli Clinical Medical College
Outcome results
None listed