hepatocellular carcinoma
Conditions
Interventions
Neoadjuvant therapy group:Neoadjuvant phase: Tislelizumab combined with Lenvatinib
Adjuvant phase: Tislelizumab combined with Lenvatinib
Adjuvant treatment group:Adjuvant phase: Tislelizumab combined with Lenvatinib
Sponsors
The First Affiliated Hospital of Military Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-75 years, no gender limit; 2. ECOG PS score 0-1; 3. Patients who meet the diagnostic criteria for hepatocellular carcinoma (Guidelines for Diagnosis and Treatment of Primary Liver Cancer 2022 Edition), patients with resectable hepatocellular carcinoma identified by surgical experts or MDT discussion and confirmed by auxiliary examination with non-main portal vein cancer embolus; 4. At least one measurable lesion (RECIST1.1); 5. Child-Pugh class A without ascites; 6. No previous local or systemic treatment; 7. There are no other related diseases that affect the systemic treatment; 8. No other systematic malignancies; 9. Normal organ function, and meet the following conditions: neutrophil >=1500/µL; Platelet >=60,000/µL; Hemoglobin > 8.5g /dL; Plasma albumin > 3.0 g/dL; Total bilirubin < 30mmol/L; ALT and AST were lower than 5 times the normal upper limit. INR < 1.7 or PT extension not exceeding 4 seconds; Blood creatinine below 1.5 times the upper limit of normal; 10. The patient himself/herself is aware of the condition and signs a written document.
Exclusion criteria
Exclusion criteria: 1. Received any antitumor therapy for liver cancer in the past; 2. Allergy to targeted drugs and immunotherapy; 3. A history of heart disease or uncontrolled hypertension (>150/100mmHg); 4. History of thrombotic disease or gastrointestinal bleeding within 6 months; 5. Patients with an active infection other than HBV/HCV (grade 2 above the NCI CTC AE version 5.0 definition) or other severe concomitant diseases that do not tolerate treatment; 6. History of other malignancies; 7. History of drug allergy; 8. Pregnant or lactating patients; 9. Patients with autoimmune diseases or other reasons requiring long-term use of glucocorticoids; 10. Other factors that may affect patient enrollment and evaluation results; 11. The investigator assessed patients with poor compliance and could not guarantee treatment and follow-up according to the study protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1-year recurrence free survival rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| 2-year recurrence free survival rate;OS;Surgical resection rate;Safety;Quality of life; | — |
Countries
China
Contacts
Public ContactJianwei Li
The Southwest Hospital of AMU
Outcome results
None listed