hepatocellular carcinoma
Conditions
Interventions
one arm:1.TACE treatment
2. Adbelimumab: 1200mg or 20mg/kg, every 3 weeks (21 days) for a cycle
3. Apatinib mesylate: 250mg, oral, qd.
Sponsors
Fujian Provincial Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age: 18-75 years old , both male and female; 2. Patients with primary hepatocellular carcinoma who strictly meet the clinical diagnostic criteria of the "Guidelines for Diagnosis and Treatment of Primary Liver Cancer" (2022 edition) or who have been confirmed by histopathology or cytology and have at least one measurable lesion (according to the requirements of mRECIST standards, the length of spiral CT scan of the measurable lesion =10mm or the short diameter of malignant lymph node =15mm); See Annex 6 for the mRECIST version); 3. Patients who have not been systematically treated before but can tolerate TACE; 4.CNLC was divided into stages IIA-IIIB; 5. The Child-Pugh classification of liver function is grade A or B (5-7 points); 6.ECOG PS score 0-1; 7. Expected survival =12 weeks; 8. If the patient has active hepatitis B virus (HBV) infection: if HBV-DNA=2000 IU/mL (if the study center only has copy/mL detection units, 2000 IU/mL, start antiviral therapy for one week, then start therapy, and be willing to receive antiviral therapy throughout the study period; Hepatitis C virus (HCV) ribonucleic acid (RNA) positive patients must receive antiviral therapy according to standard local treatment guidelines; 9. The major organs function normally and meet the following criteria: (1) The standard of blood routine examination must meet: (no blood transfusion within 14 days) a. Hemoglobin (HB) =90g/L, b. White blood cell count (WBC)=3×10^9/L c. Absolute neutrophil count (ANC)=1.5×10^9/L, d. Platelet (PLT)=75×10^9/L; (2) Biochemical examination shall meet the following standards: a. Bilirubin (BIL)<1.5 times the upper limit of normal (ULN); b. Alanine aminotransferase (ALT) and aspartate aminotransferase AST<5ULN; c. Serum creatinine (Cr) =1.5ULN (3) The coagulation function test shall meet the following criteria: a. International Standardized Ratio (INR) or APTT=1.5×ULN; 10. Women of childbearing age must have a negative pregnancy test (serum) or urine HCG test within 7 days prior to admission and be willing to use an appropriate method of contraception during the trial drug treatment and 24 weeks after the last trial drug administration; For men, surgical sterilization or consent to the use of an appropriate method of contraception during the trial drug treatment and 24 weeks after the last trial drug administration; 11. Subjects voluntarily joined the study, signed written informed consent, had good compliance, and cooperated with follow-up.
Exclusion criteria
Exclusion criteria: 1. Pregnant or lactating women; 2. Patients with cholangiocarcinoma or mixed cell carcinoma; 3. Patients with autoimmune diseases, organ/hematopoietic stem cell transplantation, or other malignancies (except cured skin basal cell carcinoma and cervical carcinoma in situ); 4. Patients with consciousness disorder or can not cooperate with treatment, combined with mental illness; 5. Patients who have participated in other clinical trials in the past three months; 6. Previous history of other malignant tumors or targeted therapy or other PD-1/ PD-L1 inhibitor therapy; 7. Received major surgery or chemotherapy or other systemic or local treatment for target lesions (including but not limited to radiation therapy, ablation therapy, etc.) within 1 month before enrollment; 8. Immunosuppressive agents or systemic hormone therapy (dose >10mg/ day prednisone or other therapeutic hormones) were used within 14 days before enrollment to achieve immunosuppression; 9. There are conjunctures for interventional therapy, such as severe cirrhosis, medium or more ascites, Child-Pugh grade C liver function, which cannot be improved by liver protection treatment, complete cancer embolism/thromboembolism in main portal vein, primary branch cancer embolism of bilateral portal vein, and little collateral blood vessel formation; 10. Esophageal (fundus) varices rupture and bleeding within 1 month before treatment; 11. Uncorrectable coagulation dysfunction and severe blood abnormalities, with a tendency to severe bleeding. Platelet count 140 mmHg, diastolic blood pressure > 90 mmHg); 17. Previous serious cardiovascular disease, including but not limited to the following diseases: Grade II or above myocardial ischemia or myocardial infarction, poorly controlled arrhythmias (including QTc interval =450 ms in men and =470 ms in women); According to NYHA criteria, patients with grade ? to ? cardiac insufficiency or left ventricular ejection fraction (LVEF) 1.0g); 19. Inability to swallow tablets, malabsorption syndrome or any condition affecting gastrointestinal absorption; 20. Patients with other concomitant diseases that, in the judgment of the investigator, endanger the patient's safety or interfere with the patient's completion of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective remission rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease control rate;Progression free survival;Overall survival; | — |
Countries
China
Contacts
Public ContactWenchang Yu
Fujian Provincial Cancer Hospital
Outcome results
None listed