unresectable hepatocellular carcinoma (BCLC stage B)
Conditions
Interventions
Experimental group:atilizumab and bevacizumab combined with TACE
Sponsors
The Third Affiliated Hospital of the Second Military Medical University of the Chinese people's Liberation Army
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 70 years; 2. Sign the informed consent; 3. The investigator believes that the patient has the ability to comply with the research protocol; 4. Histological or cytological or imaging or clinical diagnosis of hepatocellular carcinoma (HCC) (fibrous lamellar and mixed hepatocellular/cholangiocarcinoma subtypes do not meet the inclusion criteria); 5. According to the EASL clinical practice guidelines (2020 edition), the clinical stage is BCLC stage B; 6. The disease is not suitable or the patient refuses to undergo surgical treatment and/or local ablation; 7. Have not received any anti-tumor therapy in the past 12 months; 8. At least 1 measurable (measurable according to RECIST1.1), untreated lesions; 9. Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or 1 within 7 days before the first study treatment; 10. Child-Pugh Class A within 7 days before study treatment; 11. Adequate hematology and organ function, based on the following laboratory test results obtained within 7 days prior to initiation of study treatment (unless otherwise stated): (1) Absolute neutrophil count (ANC)>=1.5x10^9/L (1500/µL), without granulocyte colony-stimulating factor support; (2) Lymphocyte count >=0.5x10^9/L (500/µL); (3) Platelet count >=75x10^9/L (75,000/µL), no blood transfusion; (4) Hemoglobin >= 90 g/L (9 g/dL), in order to meet this standard, (5) Blood transfusion can be allowed to the patient; AST, ALT and alkaline phosphatase (ALP) = 50 mL/min (calculated using the Cockcroft-Gault formula); (8) Serum albumin>=28 g/L (2.8 g/dL); (9) Patients not receiving anticoagulation therapy: INR or aPTT =2+ proteinuria should collect 24-hour urine, and then must confirm that the urine protein content within 24 hours is less than 1 g. 12. Pre-treatment tumor tissue samples (if available). If tumor tissue is available, submit 1 formalin-fixed, paraffin-embedded (FFPE) tumor sample in a paraffin block (preferred), or approximately 10-15 slides containing unstained, fresh-cut, serial sections radiographs, together with a relevant pathology report within 4 weeks of enrollment. If the FFPE samples described above are not available, any type of sample (including fine needle aspiration biopsy samples, cell mass samples [eg, from pleural effusions], and lavage samples) is acceptable. A relevant pathology report should be provided with the sample. If tumor tissue is not available (e.g., exhausted due to previous diagnostic testing), the patient is still eligible to participate in the study; 13. Patients with active hepatitis B virus (HBV) infection: HBVDNA < 500IU/mL obtained within 28 days before the start of study treatment, and received anti-HBV treatment for at least 14 days before entering the study (treatment according to local standard treatment, such as entecavir) and are willing to continue receiving treatment during the study; 14. Women of childbearing age must have a negative pregnancy test (ßHCG) before starting treatment, and women of childbearing age and men
Exclusion criteria
Exclusion criteria: 1. Have a contraindication, history of hypersensitivity, or intolerance to any of the drugs used in the study; 2. History of hepatic encephalopathy; 3. Known evidence of bleeding diathesis or coagulation disorder; 4. Patients with untreated or incompletely treated esophageal and/or gastric varices with bleeding or at high risk of bleeding. Before enrollment, patients must undergo B-ultrasound, CT, MRI, or liver elastography, and all varicose veins must be assessed for size (small to large) and treated according to local standard of care. Patients who have undergone corresponding examinations within 6 months before starting study treatment do not need to undergo repeated examinations; 5. Bleeding from esophageal and/or gastric varices occurred within 6 months prior to the initiation of study treatment; 6. Abdominal fistula, gastrointestinal perforation or abdominal abscess within 6 months before starting study treatment; 7. Known active tuberculosis; 8. HIV antibody test result is positive; 9. Severe infection within 4 weeks prior to initiation of study treatment, including but not limited to hospitalization due to complications of infection, bacteremia or severe pneumonia; 10. Oral or intravenous therapeutic antibiotics within 2 weeks prior to initiation of study treatment. Patients receiving prophylactic antibiotics (eg, to prevent urinary tract infections or exacerbations of chronic obstructive pulmonary disease) are eligible to participate in the study. 11. Simultaneous infection with HBV and HCV. Patients with a history of HCV infection but negative PCR results for HCV RNA can be considered HCV-uninfected; 12. Blood pressure control is not ideal, systolic blood pressure >= 150 mmHg, diastolic blood pressure >= 100 mmHg; 13. History of uncorrectable serum potassium, calcium or magnesium electrolyte disturbances; 14. Received major surgery (except diagnosis) within 4 weeks before the start of study treatment or is expected to undergo major surgery during the study period; 15. Major cardiovascular disease within 3 months prior to initiation of study treatment (such as New York Heart Association class II or more severe heart disease, myocardial infarction, or cerebrovascular accident within 3 months prior to initiation of study treatment), unstable Arrhythmia, unstable angina or coronary heart disease; 16. History of congenital long QT syndrome or corrected QT interval at screening >500ms (calculated using Fridericia method); 17. There are serious wounds, ulcers or fractures that cannot be healed; 18. Idiopathic pulmonary fibrosis, organizing pneumonia (eg, bronchiolitis obliterans), drug-induced pneumonia, or idiopathic pneumonia or evidence of active pneumonia on chest computed tomography (CT) images during screening. Radiation pneumonitis in the permissible radiation zone (fibrosis); 19. Current or past autoimmune disease or immunodeficiency, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid antibody syndrome, Wegener's granulomatosis, Sj?gren's syndrome, Guillain-Barré syndrome, or multiple sclerosis, with the following exceptions: patients with prior autoimmune-related hypothyroidism receiving thyroid hormone replacement therapy are eligible for study participation; Patients with controlled type 1 diabetes were eligible to participate in the study; only patients with dermatologically manif
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival;Disease control rate;Progression-free survival;Time to progression;Duration of response;Conversion rate of surgical resection; | — |
Countries
China
Contacts
Public ContactWang Kang
The Third Affiliated Hospital of the Second Military Medical University of the Chinese people's Liberation Army
Outcome results
None listed