Liver Cancer
Conditions
Interventions
The test group:TACE: Using traditional iodine oil TACE, iodine oil contains the chemotherapy drug hydrochloric acid table jusphate, according to The subject's body surface area was calculated to calcu
Control group:TACE: The requirements of TACE technique are the same as in the test group
Sponsors
Cancer Hospital Affiliated to Guangxi Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. The subjects who voluntarily participated in this study signed the informed consent; 2. Subjects over 18 years old; 3. HCC patients confirmed by histopathology, cytology or imaging; 4. Patients with CNLC stage IIB IIIA (according to the standard for diagnosis and treatment of primary liver cancer, 2019 Edition); 5. There were measurable lesions in the baseline imaging examination (i.e. the long diameter of lesions on enhanced MRI or enhanced CT scan >= 10 mm or the short diameter of enlarged lymph nodes >= 15 mm); The lesions that have received local treatment in the past can be used as target lesions after definite progress; 6. Child Pugh liver function rating: Grade A or better grade B (= 12 weeks; 9. Within 7 days before enrollment, the laboratory test values met the following requirements: (1) Absolute neutrophil count (ANC) >= 1.5 x 10^9/L (2) Platelet count (PLT) >= 100 x 10^9/L (3) Hemoglobin content (Hgb) >= 9.0 g / dl; (4) Serum total bilirubin (TBIL) = 28 g / L; (8) Alkaline phosphatase (ALP) = 50ml / min (Cockcroft Gault formula); (10) Urine routine results showed that urine protein < 2 +; For the patients whose urine protein was more than or equal to 2 + at baseline, 24-hour urine collection should be performed, and the 24-hour urine protein quantity should be less than 1G. k) International normalized ratio (INR) or activated partial thromboplastin time (APTT) <= 1.5 fold ULN. 10. In case of hepatitis B virus (HBV) infection: HBV DNA must be less than 2000 IU / ml (if the research center has only copy / ml testing unit, it must be less than 104 copy / ml), Patients with positive hepatitis C virus (HCV) RNA must receive antiviral therapy according to the treatment guidelines, and their liver function is within the level of CTC AE 1; 11. Female patients of childbearing age or male patients with female sexual partners of childbearing age should take effective contraceptive measures during the whole treatment period and 6 months after the last medication.
Exclusion criteria
Exclusion criteria: 1. Patients with portal vein tumor thrombus reaching or exceeding the main portal vein or combined with left and right portal vein tumor thrombus at the same time; 2. Patients with severe allergy to iodine contrast agent and unable to receive TACE treatment; 3. Patients who are ready for or have received organ or allogeneic bone marrow transplantation in the past; 4. Current patients with interstitial pneumonia or interstitial lung disease, or patients with previous history of interstitial pneumonia or interstitial lung disease requiring hormone therapy, or other patients with pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), pneumoconiosis, drug-related pneumonia that may interfere with the judgment and treatment of immune related pulmonary toxicity Patients with idiopathic pneumonia or with evidence of active pneumonia on chest computed tomography (CT) during screening period or with severe impairment of lung function were allowed to have radiation pneumonia in the radiation field; Active tuberculosis; 5. Patients with active autoimmune disease or history of autoimmune disease and may relapse (including but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hypophysitis, vasculitis, nephritis, hyperthyroidism Hypothyroidism [can be controlled only by hormone replacement therapy]: subjects with systemic skin diseases such as epilepsy, psoriasis and alopecia without systemic treatment, controlled I diabetes or complete childhood asthma were completely relieved. Those who need no intervention in adulthood can be included: those who need bronchodilator for medical intervention can not be included; 6. Patients treated with immunosuppressant or systemic hormone within 2 weeks before randomization (dose > 10mg / day prednisone or other effective hormones); 7. The patient had active infection, fever of unknown origin >= 38.5 degrees C within 1 week before randomization, or white blood cell count > 15 at baseline x 10 ^ 9 / L: therapeutic antibiotics were given orally or intravenously within 2 weeks before randomization (patients who received prophylactic antibiotics (for example, those who prevented urinary tract infection or exacerbation of chronic obstructive pulmonary disease were eligible to participate in the study); 8. Congenital or acquired immune deficiency (such as HIV infection); 9. Patients who had received live attenuated vaccine in the first 4 weeks of randomization, or expected to receive such vaccine during the treatment of karelizumab or within 60 days after the last administration of karelizumab; 10. Subjects with a history of gastrointestinal bleeding or a clear tendency of gastrointestinal bleeding within the first 6 months of randomization, such as bleeding risk or severe esophageal and gastric varices, local active gastrointestinal ulcer lesions, and persistent fecal occult blood positive, could not be included (if fecal occult blood was positive at baseline, they could be reexamined, and if it was still positive after reexamination, they could not be included, Gastroduodenoscopy (EGD) is required. If EGD indicates the risk of bleeding, esophageal and gastric varices can not be included; 11. Patients with known hereditary or acquired bleeding (such as coagulation dysfunction) or thrombotic tendency, such as hemophilia patients, are currently receiving full dose oral or injection anticoagulants or thrombolytic drugs for treatment purposes (low-dose aspirin i
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| objective response rate, ORR;progression free survival, PFS;overall survival, OS;disease control rate, DCR;duration of remission, DoR; | — |
Countries
China
Contacts
Public ContactMaYilong
Cancer Hospital Affiliated to Guangxi Medical University
Outcome results
None listed