hepatocellular carcinoma
Conditions
Interventions
treatment group:transcatheter arterial chemoembolization + lenvatinib + Sintilimab + radiotherapy
Sponsors
Fujian Provincial Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age =18 years old and =75 years old; 2. The clinical or pathological diagnosis is consistent with primary HCC; 3. BCLC stage C, type III (VP4) portal vein cancer thrombus, no extrahepatic metastasis; 4. According to mRECIST criteria, the patient had at least one measurable lesion (measurable CT scan length =10mm and measurable lesion had not received TACE, radiotherapy, radiofrequency, freezing, and other local treatments); 5. ECOG score: 0-1; 6. Liver function Child-Pugh grade A or B; 7. Blood routine: neutrophil absolute 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 ventilation 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. Other anti-tumor therapies have been used, such as targeted drugs, PD-1, and other immunotherapy, surgery, TACE, FOLFOX systemic chemotherapy, and Huaier granule drug therapy; 2. Contraindications of TACE or radiotherapy; 3. History of allergy to the ingredients or excipients of lenvatinib and sintilimab; 4. Patients with any active autoimmune disease or with autoimmune disease and expected recurrence. Patients are taking immunosuppressive agents or systemic hormone therapy for immunosuppressive purposes; 5. Patients with =1 + proteinuria indicated by routine urine will receive 24-hour urine protein detection, and patients with =1g 24-hour urine protein; 6. Patients with other malignant tumors; 7. Patients with mental illness; 8. Pregnant or lactating women; 9. Organ transplant patients; 10. Underactive or overactive thyroid.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| overall survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| progression-free survival;objective response rate;disease control rate;safety; | — |
Countries
China
Contacts
Public ContactYan Maolin
Fujian Provincial Hospital
Outcome results
None listed