hepatocellular carcinoma
Conditions
Interventions
experimental group:TACE combines karillizumab + Sorafenib
Sponsors
The First Affiliated Hospital of Nanchang University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-70 years, male or female; 2. Histopathologic diagnosis of HCC-MVI was positive after hepatocellular carcinoma resection. 3. Postoperative TACE treatment is required; 4. No other systemic malignancy; 5. The function of vital organs meets the following requirements (no blood components, cell growth factor, white medicine, platelet drug, or anemia correction drug are allowed within 14 days before the first study) : A. Absolute count of neutrophils (ANC) >= 1.5*10^9/L; B. Platelet >= 100*10^9/L; C. Hemoglobin >= 9g/dL; D. Serum albumin >= 2.8g/dL; E. Total bilirubin <= 1.5 * ULN, ALT, AST and/or AKP <= 2.5 * ULN; F. Serum creatinine <= 1.5 * ULN or creatinine clearance rate greater than 60 mL/min; G. Activated partial thromboplastin time (APTT) and international standardized ratio (INR) <= 1.5 * ULN (for anticoagulant therapy with stable dose such as LMWH or warfarin and INR can be screened within the expected therapeutic range of anticoagulants). 6. Has fertile women subjects, and the partner not childbearing age women of male subjects, needs during the period of research and treatment, and at last use the card Rayleigh bead sheet resistance after at least 3 months and last use of sorafenib six months using an approved by the medical contraception (such as intrauterine device, the pill or condoms); 7. Subjects voluntarily participated in this study, signed informed consent, had good compliance, and cooperated with follow-up; 8. The researchers say there are benefits.
Exclusion criteria
Exclusion criteria: 1. The recovery after operation is poor, there is a single organ or multiple organ dysfunction or failure; 2. A history of bleeding in the digestive system 6 months before the first use of the drug; 3. Patients with hypertension and unable to fall into the normal range after antihypertensive drug therapy (systolic blood pressure > 140 mmHg, diastolic blood pressure > 90 mmHg) have grade I arrhythmia (including extended QTc interval > 450 ms for male and 470 ms for female) and grade I cardiac dysfunction (refer to NYHA cardiac function grade). Patients with positive urine protein; 4. Uncontrollable pleural effusion, pericardial effusion or ascites requiring repeated drainage; 5. A prior history of allergy to any component of carilizumab and sorafenib; 6. There are multiple factors that affect oral medication (such as inability to swallow, nausea, vomiting, chronic diarrhea and ileus); 7. Patients with definite bleeding tendency, including: those with local active ulcer lesions, those with fecal occult blood (++) that could not be included in the group, and those with a history of black stool and vomiting blood within 2 months; 8. Received any of the following treatments: A. Previous anti-PD-1 or anti-PD-L1 antibody treatment; B. Received any research drug within 4 weeks prior to the first use of the study drug; C. Subjects requiring systematic treatment with corticosteroids (> 10mg/day equivalent of prednisone) or other immunosuppressive agents within 2 weeks prior to the first use of the study drug, except for topical use of corticosteroids for local inflammation of the esophagus and for the prevention of allergies and nausea and vomiting.Other special circumstances, need to communicate with the sponsor.Adrenocorticosteroid replacement with > 10mg/ day dose of prednisone is permitted in the absence of active autoimmune disease; D. People who have received anti-tumor vaccine or have received live vaccine within 4 weeks before the first administration of the research drug; E. Simultaneous inclusion in another clinical study, unless it is an observational (non-interventional) clinical study or intervention clinical study follow-up; 9. A history of active autoimmune diseases, autoimmune diseases (such as interstitial pneumonia, colitis, hepatitis, pituitary inflammation, vasculitis, nephritis, hyperthyroidism, hypothyroidism, including but not limited to these diseases or syndromes); Patients with vitiligo or childhood asthma/allergy who have recovered and do not require any intervention as adults are excluded;Autoimmune hypothyroidism treated with a steady dose of thyroid hormone replacement;Type 1 diabetes with a steady dose of insulin; 10. A history of immunodeficiency, including HIV positive, or other acquired or congenital immunodeficiency disease, or a history of organ transplantation and allogeneic bone marrow transplantation; 11. Severe infection (CTC AE > level 2) occurred within 4 weeks before the first use of the study drug, such as severe pneumonia, bacteremia, and infection complications requiring hospitalization;Baseline chest imaging indicated active pulmonary inflammation, signs and symptoms of infection within 2 weeks prior to the first use of the study drug, or the need for oral or intravenous antibiotic therapy, with the exception of prophylactic antibiotic use; 12. A history of interstitial lung disease (except for radiation pneumonia without hormone therapy) and non-infectious pneumonia; 13. Patients wi
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 6 month recurrence rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| 1 year recurrence rate;OS;Adverse events; | — |
Countries
China
Contacts
Public ContactRenfeng Shan
The First Affiliated Hospital of Nanchang University
Outcome results
None listed