hepatocellular carcinoma
Conditions
Interventions
Experimental group:TACE+Lenvatinib+PD-1 antibody
Sponsors
Fujian Provincial Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-75 years, no gender limit; 2. Liver function Child-Pugh grade A; 3. Indocyanine green 15 min retention rate (ICGR-15) = 8cm; (2) The number of tumors is greater than or equal to 4, and the tumor is confined to half the liver or two adjacent lobes (IIb); (3) The tumor is limited to the hemi-liver, and the portal vein tumor thrombus is Cheng's type I and II (IIIa); 7. Patients who have not received any tumor-related targeting, immune, radiotherapy and chemotherapy before enrollment; 8. According to the RECIST 1.1 criteria, the patient has at least one measurable lesion (the measurable lesion CT/MRI scan long diameter >= 10mm, and the measurable lesion has not received local treatment such as radiotherapy and freezing); 9. Blood routine: absolute neutrophil count >= 1.5x10^9/L, Hb >= 8.5g/L, PLT >= 75x10^9/L; 10. Within 1 month after surgery, no residual tumor lesions were confirmed by imaging, and AFP was negative; 11. No history of severe arrhythmia, heart failure, etc.; no history of severe ventilatory dysfunction and severe pulmonary infection; no acute or chronic renal failure, creatinine clearance rate > 40 mL/min; 12. Females of childbearing age should agree that contraceptive measures must be used during and within 6 months after the end of medication, serum or urine pregnancy test is negative within 7 days before study enrollment, and must be non-breastfeeding patients; Men should agree to patients who must use contraception during the study period and for 6 months after the end of the study period; 13. Understand and sign the informed consent.
Exclusion criteria
Exclusion criteria: 1. The portal vein tumor thrombus is located in the main trunk or the branch of the portal vein on the opposite side of the tumor; with no hepatic vein tumor thrombus; 2. Extrahepatic metastasis or invasion of adjacent organs; 3. History of allergy to lenvatinib, PD-1 monoclonal antibody and its components; 4. Patients with any active autoimmune disease or with autoimmune disease expected to relapse (such as interstitial pneumonia, colitis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism, including but not limited to these diseases and syndromes); hypothyroidism treated with a stable dose of thyroid replacement hormone; type 1 diabetes treated with a stable dose of insulin, but excluding patients with vitiligo or cured childhood asthma/allergies who do not require any intervention in adulthood; 5. There is a history of immunodeficiency; the patient is using immunosuppressive or systemic hormone therapy to achieve the purpose of immunosuppression; 6. Patients with proteinuria whose urine routine indicates >=1+ will receive a 24-hour urine protein test, and patients with 24-hour urine protein >=1g; 7. History of other malignant tumors in the past 5 years or at the same time, except for cured basal cell carcinoma of the skin, carcinoma in situ of the cervix, and papillary thyroid carcinoma; 8. Patients with psychiatric disorders; history of psychiatric drug abuse, alcohol abuse and drug abuse.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Relapse-Free Survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective Response Rate;Rate of Marked Pathological Remission;Rate of R0 Resection; | — |
Countries
China
Contacts
Public ContactYan Maolin
Fujian Provincial Hospital
Outcome results
None listed