Hepatocellular carcinoma
Conditions
Sponsors
Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 70 years, regardless of gender; 2. Histopathological examination was diagnosed as primary hepatocellular carcinoma; 3. Child-Pugh score =2.5x10^9/L; (2) Platelets >=75x10^9/L; (3) Hemoglobin >=90g/L; (4) Serum bilirubin =32g/L; 7. Subjects not receiving anticoagulation therapy: INR or aPTT=50 mL/min. The creatinine clearance rate is estimated based on the Cockcroft-Gault formula; 9. HBV-DNA<=2000cps/ml; 10. If HBsAg(+) and/or HBcAb(+), according to the test results of HBV DNA or HCV RNA, antiviral therapy is required; 11. No allergy to contrast agents; 12. Female subjects of childbearing age must undergo a serum pregnancy test within 14 days before the start of the study treatment, and the result is negative, and they are willing to use a reliable method of contraception during the test period and 60 days after the last administration of the test drug. For male subjects whose partners are women of childbearing age, they should agree to use reliable methods of contraception during the trial period and 120 days after the last administration of the trial drug; 13. Fully understand this research and voluntarily sign an informed consent form; must be willing and able to comply with the visits, treatment plans, laboratory inspections and other requirements of the research schedule stipulated in the research schedule.
Exclusion criteria
Exclusion criteria: 1. Suffered from active malignant tumors other than HCC within 5 years before enrollment or at the same time. Except for cured localized tumors, including skin basal cell carcinoma, skin squamous cell carcinoma, superficial bladder cancer, prostate carcinoma in situ, cervical carcinoma in situ and breast carcinoma in situ; 2. Previously received systemic anti-cancer therapy for HCC (mainly including systemic chemotherapy, molecular targeted therapy and CTLA-4, PD-1/PD-L1 monoclonal antibody immunotherapy) and previously received local therapy for the liver, including such as Subjects of TACE, TAE (transhepatic artery embolization), TARE (transhepatic artery radiotherapy embolization) or local ablation therapy, radiotherapy, etc.; 3. Major cardiovascular and cerebrovascular diseases (such as New York Heart Association grade II or more serious heart disease, myocardial infarction or cerebrovascular accident), unstable arrhythmia or angina pectoris within 3 months before the start of the study treatment; or cardiac color Doppler ultrasound examination LVEF (left ventricular ejection fraction) 18s, INR>1.5, Fbg<2g/L), have bleeding tendency or are receiving thrombolysis or anticoagulation therapy; 6. Have significant clinically significant bleeding symptoms or have a clear bleeding tendency within 3 months before the first treatment, such as gastrointestinal bleeding, hemorrhagic gastric ulcer, baseline fecal occult blood++ and above, or suffering from vasculitis, etc. 7. Active infections requiring systemic treatment; 8. Human immunodeficiency virus (HIV, HIV 1/2 antibody) positive; 9. Have a history of psychotropic drug abuse, alcohol or drug abuse; 10. Other factors judged by the investigator that may affect the safety of the subjects or the compliance of the trial. For example, serious diseases (including mental illness) that require combined treatment, severe laboratory abnormalities, or other family or social factors such as drug abuse, alcohol or drug abuse history.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate;Disease control rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression free survival;Overall survival;Major pathologic response; | — |
Countries
China
Contacts
Public ContactCao Yajuan
Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School
Outcome results
None listed