study of tace combined with camrelizumab in the treatment of hcc patients

Conditions: Hepatocellular Carcinoma

Summary: it is an exploratory clinical study aimed to evaluate the efficacy and safety of tace combined with camrelizumab in the treatment of patients with bclc stage b and c hcc.treatment will continue until disease progression or intolerable toxicity or patients withdrawal of consent,and the target sample size is 60 individuals.

this is a prospective, single-center and single-arm exploratory clinical study designed to evaluate the efficacy and safety of tace combined with camrelizumab in the treatment of patients with bclc stage b and c hepatocellular carcinoma.treatment will continue until disease progression or intolerable toxicity or patients withdrawal of consent,and the target sample size is 60 individuals.

Eligibility criteria:
inclusion criteria: * 1.patients voluntarily entered the study and signed informed consent form (icf) 2. age: 18 - 80 years old and life expectancy of at least 12 weeks.; 3. clinically or histologically diagnosed as hcc; 4. there are measurable lesions that meet the recist1.1 standard on the baseline imaging examination; 5. child-pugh classification a or b (score \< 7); 6. the bclc stage is stage b or c, and it is unable or unwilling to undergo surgical treatment; 7. ecog : 0 \~ 1 ; 8. no previous immune checkpoint inhibitor treatment (including pd-1 / pd-l1 antibody and ctla-4 inhibitor); 9. hbv-deoxyribonucleic acid (dna) must be \<500iu / ml, and receive at least 14 days of anti-hbv treatment before the start of study treatment treatment; exclusion criteria: * 1. history of treatment with any local treatment (exception of liver transplantation), systemic .anti-cancer therapy, or immunotherapy; 2. those whose tumor thrombus reaches or exceeds the main portal vein; 3. existing or concurrently suffering from other malignant tumors, except for fully treated non-melanoma skin cancer, cervical carcinoma in situ, and papillary thyroid carcinoma; 4. there is any active autoimmune disease or has a history of autoimmune disease and may relapse; 5. use strong cyp3a4 / cyp2c19 inducers including rifampicin and hypericum perforatum or strong cyp3a4 / cyp2c19 inhibitors within 14 days before starting the study treatment; 6. known history of severe allergy to any monoclonal antibody; 7. patients who are going to undergo or have undergone organ or allogeneic bone marrow transplantation; 8. non-compliance with tace or camrelizumab; 9. moderate and severe ascites with clinical symptoms require therapeutic puncture, drainage, or childa-pugh score\> 2 (except imaging only shows a small amount of ascites but not accompanied by clinical symptoms); uncontrolled or moderate and above pleural effusion and pericardial effusion; 10. abdominal fistula, gastrointestinal perforation or abdominal abscess occurred within 6 months before the start of the study treatment; 11. thrombosis or embolism occurred within 6 months before the start of study treatment, such as cerebrovascular accident (including temporary ischemic attack, cerebral hemorrhage, cerebral infarction, pulmonary embolism, etc.) 12. known inherited or acquired bleeding or thrombophilia ; currently or recently (10 days prior to the start of study treatment) have used full dose oral or injection of anticoagulant drugs or thrombolytic drugs (prophylactic use of low-dose aspirin and low molecular weight heparin); 13. major vascular disease within 6 months before the study treatment; 22. past or present central nervous system metastasis; 14. metastatic diseases involving major airways or blood vessels or a large mediastinal tumor mass in the center (\ 5% bone marrow area received within 4 weeks before participating in the study;