Hepatocellular carcinoma
Conditions
Interventions
Experimental Group:Hepatic arterial infusion chemotherapy (FOLFOX) + Tislelizumab + Lenvatinib
Sponsors
Department of Hepatobiliary and Pancreatic Surgery, The Second Affiliated Hospital of the PLA Army Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age 18-75 years old, male or female; 2. ECOG PS score 0-1; 3. HCC confirmed by imaging or biopsy, and judged to be resectable by MDT; 4. Having at least one of the following high-risk recurrence factors: (1) Tumor maximum diameter > 5 cm; (2) Number of tumors > 3; (3) Edmondson grade 3-4; 5. No other local or systemic treatment in the past; 6. Child-Pugh A/B (7) grade; 7. At least one measurable lesion (RECIST1.1); 8. No other systemic malignancies; 9. Normal organ function and meet the following conditions: neutrophil >= 1500/µL; platelet >= 60,000/µL; hemoglobin > 8.5 g/dL; plasma albumin > 3.0 g/dL; total bilirubin <3 times the upper limit of normal; ALT and AST less than 5 times the upper limit of normal; INR <1.7 or PT extension does not exceed 4 seconds; serum creatinine less than 1.5 times the upper limit of normal; 10. The patient is aware of the condition and signs a written informed consent.
Exclusion criteria
Exclusion criteria: 1. Patients with contraindications to surgical resection and immunotherapy; 2. Patients with severe impairment of other important organs such as heart, lung, and kidney, who cannot tolerate treatment; 3. Patients with active infections other than HBV/HCV (more than level 2 defined by NCI CTC AE version 5.0) or other serious comorbidities, who cannot tolerate treatment; 4. Patients with acute or chronic active hepatitis B or hepatitis C infection, hepatitis B virus HBV DNA >= 200,000 IU/ml or 10^6 copies/ml; hepatitis C virus HCV RNA >= 10^3 copies/ml; hepatitis B surface antigen (HbsAg) and anti-HCV Antibody positive at the same time; 5. Patients with autoimmune diseases or other reasons requiring long-term use of glucocorticoids; 6. Patients known or suspected to be allergic to the study drug or any drug given in connection with this trial; 7. History of organ transplantation; 8. Pregnant or lactating women; 9. Patients who have participated in or are participating in other clinical trials within six months; 10. Other factors that may affect patient enrollment and evaluation results; 11. Patients whose compliance is poor as assessed by the investigator and who cannot be guaranteed to be treated and followed up according to the study protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1-year recurrence-free survival rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate in the neoadjuvant stage;Major pathological response;Complete pathological response;Recurrence-free survival;Overall survival; | — |
Countries
China
Contacts
Public ContactLu Zheng
The Second Affiliated Hospital of the Army Medical University
Outcome results
None listed