Hepatocellular carcinoma with high risk of recurrence
Conditions
Interventions
Study Group:Induction therapy using tislelizumab in combination with lenvatinib and HAIC, followed by maintenance tislelizumab monotherapy.
Sponsors
The First Affiliated Hospital of Wenzhou Medical University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Patients confirmed by imaging to have hepatocellular carcinoma (HCC); 2.Male or female patients over 18 years old; 3.Child Pugh liver function grade A; 4.HCC patients who have previously received curative treatment (such as surgical resection or liver transplantation) or have not received any treatment for hepatocellular carcinoma; 5.The ECOG (Eastern Collaboration Group Oncology Group) score before the first administration of the study was 0 or 1; 6.Expected survival time is at least 6 months; 7.Before administration, the organ function level meets the requirements and is tolerant to surgery. Important organ functional indicators meet the following requirements: hemoglobin>= 90g/L, neutrophil count>= 1.5 × 10^9/L, platelet count >= 80 × 10^9/L; aspartate transaminase or alanine transaminase = 30g/L; Serum creatinine= 60 mL/min; 8.According to the preoperative assessment by researchers, the patient has a high risk of recurrence and meets one or more of the following conditions: 1.Ib: There are 2-3 tumors with a single diameter>5cm and a maximum diameter = 10mm or CT/MRI scan short diameter >= 15mm, and the lesion has not received radiotherapy, cryotherapy, or other local treatments); 10.Women of childbearing age must use reliable contraceptive methods or undergo pregnancy tests (serum or urine) within 7 days before enrollment, with negative results, and agree to use appropriate contraceptive methods during the trial period and within 8 weeks after the last administration of the study drug. For males, they must agree to use appropriate contraceptive methods or undergo surgical sterilization during the trial period and within 8 weeks after the last administration of the study drug. 11.The patient voluntarily participates in this study and provides a signed informed consent form to cooperate with postoperative follow-up;
Exclusion criteria
Exclusion criteria: 1.Any patient who has received treatment but still has residual tumors; 2.Extrahepatic metastasis of primary liver cancer; 3.Previous or concurrent malignant tumors of the subject; 4.Diffuse liver cancer with tumor burden >= 50% of liver volume; And/or portal vein invasion classified as type IV; And/or thrombosis of inferior vena cava tumors. 5.Contraindications for hepatic arterial infusion chemotherapy (HAIC) treatment. 6.Significant clinical bleeding or bleeding tendency within 3 months prior to enrollment or currently undergoing thrombolytic or anticoagulant therapy; 7.Have a history of autoimmune diseases or require long-term use of immunosuppressants; 8.History of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS); 9.Other factors that prevent patients from undergoing surgery; 10.Existence of alcohol dependence, mental illness, pregnancy (or breastfeeding), or other conditions unsuitable for clinical trials.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1-year recurrence-free survival rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival; | — |
Countries
China
Contacts
Public ContactShan yunfeng
The First Affiliated Hospital of Wenzhou Medical University
Outcome results
None listed