Hepatocellular carcinoma
Conditions
Interventions
HAIC group:Hepatic Artery Infusion Chemotherapy
Sponsors
The Affiliated Hospital of Qingdao University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: All participants must meet the following standard set, just have to enter the test qualifications: 1. Volunteered for this study, signed informed consent; 2. Age 18 or more; 3. HCC participants diagnosed by histopathology, cytology or imaging; 4. After the eradicative resection of liver cancer participants with microvascular invasion (according to the 2019 edition of the "guidelines for primary liver cancer diagnosis and treatment"); 5. The Child - Pugh, liver function grade: A level (=1.5 x 10^9/L; Platelet >= 75 x 10^9/L; Hemoglobin >=90 g/L. (2) Biochemical examination: Serum albumin >= 30 g/L; Serum total bilirubin = 2+, 24-hour urinary protein can be quantified, and 24-hour urinary protein < 1.0g can be included in the group; 9. If people with hepatitis b virus (HBV) infection, such as HBsAg positive, HBV-DNA shall be tested, and HBV-DNA must be < 2000 IU / ml (if the research center has only copy / ml testing unit, it must be < 104 copy / ml), and anti HBV treatment shall be received at least 1 week before randomization, and they are willing to receive antiviral treatment throughout the study period, hepatitis C virus (HCV) RNA positive patients must receive antiviral treatment according to the treatment guidelines; 10. Women with fertility: they must agree to abstinence (avoiding heterosexual intercourse) or use reliable and effective contraceptive methods from the signing of informed consent to at least 120 days after the last administration of the study drug. The serum hCG test must be negative within 1 week before randomization; And must be non lactation. If a female patient has menstruation, has not yet reached postmenopausal state, or has no menstruation for more than 12 months, and no other reason is found except menopause), and has not received sterilization surgery (such as hysterectomy, bilateral tubal ligation or bilateral oophorectomy), the patient is considered to be fertile; 11. Male subjects whose partners are fertile women must agree to abstinence or use reliable and effective contraceptive methods from the signing of informed consent to at least 120 days after the last administration of the study drug. Male subjects must also agree not to donate sperm during the same period of time. Male subjects whose partners are pregnant must use condoms and do not need to use other contraceptive methods.
Exclusion criteria
Exclusion criteria: The participants meet the following criteria, shall be included in the study: 1. Not completely radical resection of liver cancer surgery patients; 2. Patients with severe allergy to iodine contrast medium; 3. Prepare for or ever received organ or the same allogeneic bone marrow transplantation of patients; 4. Now with interstitial pneumonia or interstitial lung disease, or has a hormone treatment of interstitial pneumonia, history of interstitial lung disease, or other may interfere with the immune related lung toxicity judgment and treatment of lung fibrosis, machine pneumonia (for example, occlusive bronchiolitis), pneumoconiosis, drug related pneumonia, idiopathic pneumonia or visible on the screening phase of chest CT map active pneumonia evidence or severe lung function damage of the subjects, allowing the radiation field has active TB radiation pneumonia; 5. Active autoimmune disease or history of autoimmune disease and possible recurrence (including but not limited to autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hypophysitis, vasculitis, nephritis, hyperthyroidism and hypothyroidism (subjects that can be controlled only by hormone replacement therapy can be included)). Subjects with systemic skin diseases such as vitiligo, psoriasis, alopecia, or controlled type I diabetes were treated with insulin therapy, asthma has been completely relieved in childhood as well as without any intervention in adults can be included; Asthma patients who need bronchodilators for medical intervention cannot be included; 6. Immunosuppressant or systemic hormone therapy was used within the first 2 weeks of randomization to achieve the purpose of immunosuppression (dose > 10mg / day, prednisone or other effective hormones); 7. Patients with active infection, unexplained fever within 1 week before randomization > = 38.5 degrees C, or leukocyte count in screening period > 15 x 10^9/L Therapeutic antibiotics were given orally or intravenously within 2 weeks before randomization (excluding prophylactic antibiotics given intravenously for no more than 48 hours); 8. Patients with congenital or acquired immune function defects (such as HIV infection); 9. Received live attenuated vaccine treatment within the first 4 weeks of randomization, or expected to be vaccinated during the treatment of carrelizumab or within 60 days after the last administration of carrelizumab; 10. Significant clinical bleeding symptoms or definite gastrointestinal bleeding tendency occurred within the first 6 months of randomization, such as severe esophageal and gastric varices, local active gastrointestinal ulcer lesions or vasculitis. If the stool occult blood is positive in the screening period, it can be rechecked. If it is still positive after recheck, gastroscopy is required; 11. Patients with known hereditary or acquired bleeding (such as coagulation dysfunction) and thrombotic tendency, such as hemophilia, are currently receiving full-dose oral or injection anticoagulants or thrombolytic drugs for therapeutic purposes (preventive use of low-dose aspirin, etc.); 12. Arterial thromboembolism events occurred within the first 6 months of randomization, such as cerebrovascular accidents (including transient ischemic attack, intracerebral hemorrhage and cerebral infarction), deep venous thrombosis above CTCAE grade 3, pulmonary embolism, etc; 13. There are cardiac clinical symptoms or diseases that are not well controlled, such as: (1) According
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease-free survival (DFS); | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival (OS); | — |
Countries
China
Contacts
Public ContactLi Jian
The Affiliated Hospital of Qingdao University
Outcome results
None listed