hepatocellular carcinoma
Conditions
Interventions
experimental group:TACE combined with/or HAIC was administered within 3 working days after enrollment. Adebrelimab plus bevacizumab was administered 4-6 days after surgery (every 3 weeks) depending on
Sponsors
The First Affiliated Hospital of Soochow University
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: All participants must meet the following standard set, just have to enter the test qualifications: 1. Volunteered for this study, signed informed consent; 2. Age = 18 one full year of life, men and women are not limited; 3. Hepatocellular carcinoma confirmed by histopathology, cytology, or imaging; 4. CNLC IIb/IIIa/stage IIIb or BCLC stage B/C hepatocellular carcinoma (HCC) patients; 5. No prior systemic therapy for hepatocellular carcinoma; 6. No previous TACE or HAIC treatment; 7. Child-Pugh liver function: A-B grade (= 9 points); 8. ECOG PS score: 0-1; 9. The laboratory test values within 10 days before enrollment meet the following requirements: (1) Blood routine examination: (except hemoglobin, no blood transfusion, no G-CSF, and no medication correction within 2 weeks before screening) : ? Absolute neutrophil count =1.5×109/L; ? Platelet =50×109/L; ? hemoglobin =90 g/L; (2) and biochemical examination: ? Serum albumin =30g/L; ? serum total bilirubin 1.5 x ULN or less; ? ALT and AST 3 x ULN or less; ? Serum creatinine =1.5×ULN; Or Cr clearance > 50 ml/min (3) International normalized ratio (INR) =1.2 or prothrombin time (PT) beyond the normal range =2 seconds; (4) urine protein < 2 + (p + 2 if the urine protein, can be quantitative (h) 24 hours urinary protein, 24 h urine protein quantitative < 1.0 g can group); 10. If people with hepatitis b virus (HBV) infection, such as HBsAg positive, detection of HBV DNA, and HBV DNA to < 2000 IU/mL (if research center only copy/mL detection unit, you must < 104 copy/mL); Participants with HBV-DNA of at least 2000 IU per milliliter received antiviral therapy (only nucleoside agents such as entecavir, tenofovir dipivoxil fumarate, and tenofovir propofol fumarate tablets were allowed) for at least 1 week before enrollment and had a decrease in viral copy number by a factor of more than 10 (1 lg). For patients with HBV infection, antiviral therapy should be received throughout the study period. Hepatitis c virus (HCV) RNA positive subjects must be according to the guidelines of antiviral therapy; 11. Women of childbearing age must have a negative (ß-HCG) pregnancy test before starting the first dose of medication. Women of reproductive age and men (who have sex with a woman of reproductive age) must agree to contraception during treatment and within 6 months of the last dose.
Exclusion criteria
Exclusion criteria: Subjects were not included in the study if they met any of the following conditions: 1. Known intrahepatic cholangiocarcinoma, sarcomatoid hepatocellular carcinoma, mixed cell carcinoma (ICC component > 30%), and fibrolamellar cell carcinoma; Patients with active malignant tumors other than HCC within 5 years or at the same time; Into the group assessed by the researchers need to do before surgery with radiofrequency ablation therapy. Localized tumors that had been cured, such as skin basal cell carcinoma, skin squamous cell carcinoma, superficial bladder cancer, prostate cancer in situ, cervical cancer in situ, and breast cancer in situ, could be enrolled. 2. Patients with current interstitial pneumonia or interstitial lung disease, or a previous history of interstitial pneumonia or interstitial lung disease requiring steroid therapy, or other pulmonary fibrosis, organizing pneumonia (e.g., Occlusive bronchiolitis), pneumoconiosis, drug related pneumonia, idiopathic pneumonia or phase in the screening of chest CT shows with active pneumonia or severely damaged lung function of the subjects; Active TB; 3. There is active autoimmune disease or a history of autoimmune disease and may recur [including but not limited to autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, the pituitary gland inflammation, vasculitis, nephritis, thyroid function, thyroid function decrease (only by hormone replacement therapy can control subjects into groups)]; Patients with skin diseases requiring no systemic treatment such as vitiligo, psoriasis, alopecia, controlled type I diabetes treated with insulin, or asthma that had been completely relieved in childhood without any intervention in adulthood were eligible. Patients with asthma who required medical intervention with a bronchodilator were excluded. 4. Use of immunosuppressive agents or systemic corticosteroids to achieve immunosuppression within 2 weeks before enrollment (dose >10mg/ day of prednisone or other effective hormones); 5. Patients with active infection, into the group of fuo in 1 week before 38.5 ? or higher, or baseline period leukocyte count > 15 x 109 / L; Therapeutic oral or intravenous antibiotics were administered within 2 weeks before enrollment (with the exception of prophylactic intravenous antibiotics administered for no more than 48 hours). 6. Patients with congenital or acquired immune function defects (such as HIV infected people); 7. Have received a live attenuated vaccine within 4 weeks before enrollment or are expected to require such vaccine during treatment or within 60 days after the last dose; 8. Patients with clinically significant bleeding symptoms or clear bleeding tendency within 6 months before enrollment, such as gastrointestinal bleeding, severe esophagogastric varices, hemorrhagic gastric ulcer, or angiitis, could be reexamined if fecal occult blood was positive at baseline. 9. Known inherited or acquired bleeding (e.g. coagulopathy) or thrombophilia, such as in hemophilia patients, coagulation disorders, thrombocytopenia, etc.; Currently receiving full-dose oral or injectable anticoagulant or thrombolytic therapy (prophylactic use, such as low-dose aspirin, was allowed); 10. Major vascular disease (aortic aneurysm requiring surgical repair or recent peripheral arterial thrombosis, arterial thromboembolic events, such as cerebrovascular accident: transient ischemic attack, cerebral hemorrhage, cerebral infarction, CTCAE3 or above deep vein thrombosis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| OS;PFS;DCR; | — |
Countries
China
Contacts
Public ContactXiaoli Zhu
The First Affiliated Hospital of Soochow University
Outcome results
None listed