liver cancer
Conditions
Interventions
Experimental group:Camrelizumab for Injection+sorafenib+TACE
control group:sorafenib+TACE
Sponsors
The Second Affiliated Hospital of Nanchang University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 70 years, both male and female; 2. After liver cancer resection; 3. Postoperative TACE treatment is required; 4. Not associated with other systemic malignant tumors; 5. The functions of vital organs meet the following requirements (any blood components, cell growth factors, whitening drugs, platelet increasing drugs, and anemia correction drugs are not allowed to be used within 14 days before the first use of the research drug): (1) Absolute neutrophil count (ANC) >= 1.5x10^9/L; (2) Platelets>=100x10^9/L; (3) Hemoglobin>=9g/dL; (4) Serum albumin>=2.8g/dL; (5) Total bilirubin<=1.5xULN, ALT, AST and/or AKP<=2.5xULN; (6) Serum creatinine<=1.5xULN or creatinine clearance rate greater than 60mL/min (Cockcroft-Gault, see Annex II); (7) Activated partial thromboplastin time (APTT) and international normalized ratio (INR) <= 1.5 x ULN (for the use of stable dose anticoagulant therapy such as low molecular weight heparin or warfarin and INR in anticoagulant expected treatment range can be filtered). 6. Female subjects of childbearing potential, and male subjects with partners of women of non-fertile age, need to be on study treatment, and at least 3 months after the last dose of camrelizumab and the last dose of solute. Rafenib for 6 months using a medically approved contraceptive method (such as an IUD, birth control pill, or condom); 7. The subjects voluntarily joined the study, signed the informed consent form, had good compliance, and cooperated with the follow-up; 8. The researcher believes that there is a benefit.
Exclusion criteria
Exclusion criteria: 1. Poor recovery after surgery, with single or multiple organ dysfunction or even failure; 2. There is a history of gastrointestinal bleeding within 6 months before the first medication; 3. Patients with high blood pressure that cannot be reduced to the normal range after antihypertensive drug treatment (systolic blood pressure>140mmHg, diastolic blood pressure>90mmHg), with above grade I arrhythmias (including QTc interval prolongation>450ms in men and >470ms in women ) and grade I cardiac insufficiency (refer to NYHA cardiac function classification); patients with positive urine protein; 4. There is uncontrollable pleural effusion, pericardial effusion or ascites that requires repeated drainage; 5. History of allergy to any component of camrelizumab and sorafenib; 6. There are various factors that affect oral drugs (such as inability to swallow, nausea, vomiting, chronic diarrhea and intestinal obstruction, etc.); 7. Patients with a clear bleeding tendency, including: those with locally active ulcer lesions, and fecal occult blood (++) is not eligible for inclusion, and those who have a history of melena and hematemesis within 2 months, etc.; 8. Received any of the following treatments: (1) Received anti-PD-1 or anti-PD-L1 antibody treatment in the past; (2) Received any investigational drug within 4 weeks before the first use of the investigational drug; (3) Subjects who need to be given corticosteroids (>10mg prednisone equivalent dose per day) or other immunosuppressants for systemic treatment within 2 weeks before the first use of the study drug, except for local inflammation of the esophagus and the prevention of allergy and nausea, Vomiting when corticosteroids are used. In other special circumstances, it is necessary to communicate with the sponsor. In the absence of active autoimmune disease, inhaled or topical steroids and adrenal corticosteroid replacement at therapeutic doses >10 mg/day of prednisone are permitted; (4) Those who have been vaccinated with anti-tumor vaccines or have been vaccinated with live vaccines within 4 weeks before the first administration of the study drug; (5) Enroll in another clinical study at the same time, unless it is an observational (non-interventional) clinical study or an interventional clinical study follow-up. 9. Active autoimmune disease, history of autoimmune disease (such as interstitial pneumonia, colitis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism, including but not limited to these disease or syndrome); except for vitiligo or cured childhood asthma/allergies who do not require any intervention in adulthood; autoimmune-mediated hypothyroidism treated with stable doses of thyroid replacement hormones; use of stable doses of insulin type 1 diabetes; 10. Have a history of immunodeficiency, including HIV positive test, or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation and allogeneic bone marrow transplantation; 11. Serious infection (CTCAE greater than grade 2) occurred within 4 weeks before the first use of the study drug, such as severe pneumonia, bacteremia, infectious complications, etc. requiring hospitalization; baseline chest imaging examinations suggest the presence of active pulmonary inflammation . Symptoms and signs of infection within 2 weeks before the first use of the study drug or the need for oral or intravenous antibiotic treatment, except for the use of prophylactic antibi
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Recurrence rate at 6 months after surgery; | — |
Secondary
| Measure | Time frame |
|---|---|
| The recurrence rate at 1 year after surgery; | — |
Countries
China
Contacts
Public ContactLiao WenJun
The Second Affiliated Hospital of Nanchang University
Outcome results
None listed