hepatocellular carcinoma
Conditions
Interventions
experimental group:TACE+ adbelimumab + apatinib mesylate
Sponsors
Jiangsu Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Voluntarily participate in this study and sign informed consent; 2. Age =18 years old, male or female; 3. Hepatocellular carcinoma confirmed by histopathology, cytology, or imaging; (4) patients with CNLC stage IIb/IIIa/ IIIb or BCLC stage B/C HCC (patients with diffuse lesion stage B3 and VP3-4 were excluded); 5. PD/SD with an interval of =4 weeks from the first dose, with no previous systemic therapy for hepatocellular carcinoma, or with only previous first-line systemic therapy/surgical resection for hepatocellular carcinoma; 6. Patients who had not previously received TACE or who had received TACE with an interval of =4 weeks (patients with TACE resistance were excluded); 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) Biochemical examination: ? Serum albumin =30g/L; ? Serum total bilirubin =1.5×ULN; ?ALT and AST =3×ULN; ? 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) urinary protein <2+ (if urinary protein =2+, 24-hour urinary protein quantification could be performed, and 24-hour urinary protein quantification <1.0g could be enrolled); 10. If you have hepatitis B virus (HBV) infection, if HBsAg is positive, HBV-DNA should be tested, and HBV-DNA should be <2000 IU/mL (<104 copy/mL if the research center has only copy/mL testing unit); 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 receive antiviral therapy according to treatment guidelines. 11. Women of childbearing age must have a negative pregnancy test (ßHCG) 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: 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; Patients who needed surgery combined with radiofrequency ablation were assessed by the investigator before enrollment. 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., Bronchiolitis obliterans), pneumoconiosis, drug-associated pneumonia, idiopathic pneumonia, or active pneumonia or severely impaired lung function on chest CT during the screening period; Active tuberculosis; 3. Presence of active autoimmune disease or a history of autoimmune disease with potential recurrence (including but not limited to autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hypophysitis, vasculitis, nephritis, hyperthyroidism, and hypothyroidism (eligible if controlled only with hormone replacement therapy); 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, unexplained fever =38.5? within 1 week before enrollment, or baseline white blood cell count >15×109/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 deficiency (such as HIV infection); 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. Arterial thromboembolism events occurred within 6 months before enrollment, such as cerebrovascular accident (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), CTCAE3 or above deep vein thrombosis, pulmonary embolism, etc. 11. Have uncontrolled cardiac clinical symptoms or diseases, such as: (1) according to the New York Heart Association (NYHA) standard II or abo
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS6; | — |
Secondary
| Measure | Time frame |
|---|---|
| OS;PFS;ORR;DCR;AE; | — |
Countries
China
Contacts
Public ContactQingyu Xu
Jiangsu Cancer Hospital
Outcome results
None listed