Hepatocellular carcinoma
Conditions
Interventions
Experimental group:Donafinil and Sintilimab
Sponsors
The First Affiliated Hospital of Guangxi Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 75 years (including cut-off value), no gender limit; 2. HCC confirmed by histology may meet the clinical diagnostic criteria of HCC in the "Primary Liver Cancer Diagnosis and Treatment Specification (2019 Edition)"; 3. For locally advanced HCC or with distant metastasis that cannot receive radical treatment, at least one measurable lesion that meets the definition of RECIST v1.1 standard; 4. Child-Pugh assessment of liver function =90 g/L (2) The absolute value of neutrophils (ANC) >=1.5x10^9 /L, (3) Platelet count (PLT) >=75x10^9/L; (4) Serum albumin ALB>=28g/L (5) Alanine aminotransferase (ALT), aspartate aminotransferase (AST) =50 mL/min (8) Electrolytes (phosphorus, calcium, magnesium, potassium) >= LLN; (9) Urine protein =2+, 24-hour urine protein quantitative test must be <=1.0 g/L before being selected); (10) International standard ratio (INR) or prothrombin time (PT)<=1.5xULN; activated partial coagulation time (aPTT)<=1.5xULN 8. For female patients with fertility (referring to not menopausal or surgical sterilization), the serum pregnancy test results must be negative within 14 days before enrollment; 9. Patients voluntarily join the group, can provide written informed consent, and can understand and follow the trial protocol to take medication and follow-up
Exclusion criteria
Exclusion criteria: 1. Pathologically diagnosed as hepatocellular carcinoma-intrahepatic cholangiocarcinoma (HCC-ICC) mixed type or fibrolamellar hepatocellular carcinoma; 2. Have received systemic treatment for HCC in the past, including targeted drug therapy such as sorafenib, lenvatinib, and regorafenib, or treatment with immunomodulators such as anti-PD-1 and anti-PD-L1, except for antiviral therapy Treatment; if the patient has used traditional Chinese medicine with anti-tumor indications in the past, it must be> 2 weeks or 5 drug half-lives (whichever is longer) after the treatment is completed and before the drug in this study, and adverse events caused by systemic treatment Patients who have not recovered to <= CTCAE Grade 1; 3. Have received an organ transplant in the past or plan to receive an organ transplant during the research period; Suffering from other malignant tumors within 4.5 years, unless the patient has received possible curative treatment and there is no evidence of the disease within 5 years, but this time requirement (that is, within 5 years) does not apply to skin basal cell carcinoma and skin that have been successfully removed Patients with squamous cell carcinoma, superficial bladder cancer, cervical carcinoma in situ or other carcinoma in situ; 5. Past or present suffering from congenital or acquired immunodeficiency diseases; 6. Active or previously recorded autoimmune diseases or inflammatory diseases (including but not limited to: autoimmune hepatitis, interstitial pneumonia, inflammatory bowel disease, systemic lupus erythematosus, vasculitis, uveitis, Hypophysitis, hyperthyroidism or hypothyroidism, asthma that requires bronchodilator therapy, etc.), people with vitiligo or asthma that has been completely relieved in childhood, and adults without any intervention can be included; 7. Have active bleeding or abnormal blood coagulation, have bleeding tendency or are receiving thrombolysis, anticoagulation or antiplatelet therapy; 8. There are uncontrollable hepatic encephalopathy, hepatorenal syndrome, ascites, pleural effusion or pericardial effusion; 9. Suffer from diseases that affect the absorption, distribution, metabolism or clearance of the study drug (such as severe vomiting, chronic diarrhea, intestinal obstruction, malabsorption, etc.); 10. Major surgery (defined by the investigator) within 4 weeks before enrollment, or major surgery is expected during the study treatment period (except liver resection and liver transplantation); 11. Have received allogeneic stem cell or solid organ transplant in the past; 12. Patients need to take strong CYP3A4 inducer drugs in combination; 13. At the same time taking drugs that may prolong QTc and/or induce torsade de pointes (Tdp) or drugs that affect drug metabolism; 14. Patients who are known or suspected to have a history of allergy to Donafenib or similar drugs, or have a history of hypersensitivity to chimeric or humanized antibodies or fusion proteins, or who are allergic to the excipients of the study drug; 15. A history of gastrointestinal bleeding in the past 4 weeks or a clear gastrointestinal bleeding tendency (eg: known local active ulcer lesions, fecal occult blood++ or more, if persistent fecal occult blood+, gastroscopy should be performed), Or other conditions determined by the investigator that may cause gastrointestinal bleeding (such as severe fundus of the stomach/esophageal varices); 16. Gastrointestinal perforation, abdominal fistula or abdom
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival;Overall survival;safety; | — |
Countries
China
Contacts
Public ContactMa Jie
The First Affiliated Hospital of Guangxi Medical University
Outcome results
None listed