advanced hepatocarcinoma
Conditions
Interventions
Experimental group:Deb-tace was loaded with A PD-1 inhibitor
Sponsors
The First Affiliated Hospital of Nanchang University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 75 years; 2. Primary liver cancer was diagnosed by histopathology or clinical imaging (according to the Guidelines for the Diagnosis and Treatment of primary Liver cancer 2019 edition) and assessed as unresectable; 3. Liver tumors were treated without interventional therapy (TACE, ablation, iodine particle therapy, etc.) and FOLFIRI for 3 months; 4. The expected survival time is more than 3 months. 5. Liver function is good (Child-pugh grade A or B 7); 6. Physical fitness ECOG <=1 score; 7. Understand and sign the informed consent form. 8. No other systemic malignancies; 9. 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); 10. The subjects voluntarily joined the study and signed the informed consent, with good compliance and follow-up; Researchers think they can.
Exclusion criteria
Exclusion criteria: 1. Patients with distant metastasis of tumor other than liver; 2. Those with obvious arterial/venous fistula; 3. The tumor thrombus of the main portal vein and the left and right branches of the portal vein are completely blocked at the same time; 4. Patients with iodine allergy; 5. White blood cell 2mg/L); 7. AST and/or ALT > 5 times the upper limit of normal; 8. Poor coagulation function, INR>1.5, or ongoing anticoagulation therapy or known bleeding disorders; 9. History of major diseases involving the heart, kidneys, bone marrow or lungs, central nervous system; 10. History of hypersensitivity to any component of camrelizumab; 11. Received any of the following treatments: Previous anti-PD-1 or anti-PD-L1 antibody treatment; Received any investigational drug within 4 weeks prior to first dose of study drug; Needed to administer corticosteroids (daily) within 2 weeks prior to first dose of study drug >10mg prednisone equivalent dose) or other immunosuppressants for systemic treatment, except for the use of corticosteroids for local inflammation of the esophagus and the prevention of allergy and nausea and vomiting. 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 an effective dose of prednisone >10 mg/day are allowed; 4 weeks before the first dose of antitumor vaccine or study drug Have been vaccinated with live vaccines in the past; be enrolled in another clinical study at the same time, unless it is an observational (non-interventional) clinical study or follow-up of an interventional clinical study; 12. Active autoimmune disease, history of autoimmune disease (eg, interstitial pneumonia, colitis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism, including but not limited to these diseases 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 hormone; I with stable doses of insulin type diabetes; 13. A history of immunodeficiency, including a positive HIV test, or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation and allogeneic bone marrow transplantation; 14. Serious infection (CTCAE greater than grade 2) occurred within 4 weeks before the first use of the study drug, such as severe pneumonia requiring hospitalization, bacteremia, infectious complications, etc.; Symptoms and signs of infection or need for oral or intravenous antibiotics within 2 weeks prior to study drug use, except for prophylactic antibiotics; 15. Any other malignancy diagnosed within 5 years prior to the first use of the study drug; 16. pregnant or breastfeeding women; 17. According to the judgment of the investigator, the subjects have other factors that may cause them to be forced to terminate the study halfway, such as other serious diseases (including mental diseases) that require concomitant treatment, severely abnormal laboratory test values, and family or social factors, which may affect the study. to the situation of subject trial data collection; 18. Investigators deemed inappropriate for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival;Conversion rate; | — |
Countries
China
Contacts
Public ContactPeng Xiaodong
The First Affiliated Hospital of Nanchang University
Outcome results
None listed