Hepatocellular carcinoma (HCC)
Conditions
Interventions
Yttrium [90Y] microsphere injection combined with systemic therapy:Yttrium [90Y] resin microsphere combined with targeted drugs and immune checkpoint inhibitors
TACE combined with systemic therapy:TACE combined with targeted drugs and immune checkpoint inhibitors
Sponsors
Shulan (Hangzhou) Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Voluntarily sign the informed consent form; 2. Age >= 18 years and = 1cm) according to the modified Response Evaluation Criteria in Solid Tumors (mRECIST); 10. The subject's major organ functions are normal and meet the following requirements: (1) Blood routine: Hemoglobin >= 80 g/L; platelet count > 50×10^9/L; absolute neutrophil count (ANC) >= 1.5×10^9/L; (2) Blood biochemistry: Albumin > 30 g/L; total bilirubin (TBil) = 40 ml/min; (3) Coagulation function: International normalized ratio (INR) or prothrombin time (PT) = 6 months.
Exclusion criteria
Exclusion criteria: 1. History of other malignant tumors within the past 5 years or concurrent other malignant tumors (except for appropriately treated or resected non-metastatic basal cell or squamous cell skin cancer, in situ cervical cancer, or ductal carcinoma in situ of the breast); 2. Hepatic encephalopathy (HE); 3. Central nervous system (CNS) metastasis (if CNS metastasis is suspected, CT/MRI must be performed within 4 weeks prior to enrollment to exclude CNS metastasis); 4. Prior external beam radiotherapy to the liver with an unclear radiotherapy plan, or planned extrahepatic radiotherapy during the study period; 5. Patients who have received hepatic arterial infusion chemotherapy (HAIC) within the past 1 month or plan to receive HAIC during the study; 6. Multiple tumors in both lobes with >5 nodules (fusion lesion count as 1) or tumor burden >70%, or lesions diffusely distributed making calculation difficult; 7. Presence of main portal vein tumor thrombus without formed collateral circulation; i.e., Japanese classification Vp4 type; 8. Pregnant or nursing; 9. Active infections requiring systemic therapy (except for active hepatitis B or C); 10. Severe allergy to iodine contrast agents; 11. Autoimmune diseases deemed by the investigator as unsuitable for study participation; 12. Severe cardiovascular, cerebrovascular, or pulmonary diseases deemed by the investigator as unsuitable for study participation; 13. Positive human immunodeficiency virus antibody (HIV Ab); 14. Patients currently participating in other drug or device clinical trials; 15. Any other circumstances considered by the investigator as unsuitable for participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of downstaging ; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate(ORR);Disease control rate(DCR);Pathological response rate;Surgical rate after successful downstaging;Surgical rate after successful conversion;Recurrence-free survival;Recurrence-free survival rate;Overall survival;Overall survival rate;Progression-free survival;Progression-free survival rate;Time to progression (TTP); | — |
Countries
China
Contacts
Public ContactShusen Zheng
Shulan (Hangzhou) Hospital
Outcome results
None listed