Hepatocellular Carcinoma
Conditions
Interventions
Treatment Group:TACE combined with Atelizumab and bevacizumab(Atrilizumab 1200 mg and bevacizumab 15 mg/kg were administered by IV infusion on day 1 of each cycle (one cycle every 21 days) as an initi
If subjects do not meet the resectable criteria for conversion therapy after 3 cycles of TACE therapy combined with T+A, they may continue to receive T+A therapy for 3 cycles and then re-evaluate the
Sponsors
Nanjing Drum Tower Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1) Join the group voluntarily and sign a written informed consent; (2) Age 18 ~ 80 years old (including 80 years old), male and female (3) Clinically diagnosed or histologically/cytologically confirmed as unresectable locally advanced hepatocellular carcinoma in accordance with the Guidelines for the Diagnosis and Treatment of Primary Liver Cancer (2022 Edition); (4) did not receive systematic anti-tumor therapy. (5) The portal vein has no major vascular invasion (Vp3 or Vp4) or the hepatic vein or inferior vena cava has no major vascular invasion of any level. (6) There is at least one evaluable lesion (RECIST 1.1 criteria); (7) Expected survival time =3 months; (8) The physical status (PS) score of ECOG was 0 ~ 1; (9)Child-Pugh grade A; (10) Major organ function is normal, that is, meet the following criteria: routine blood test: hemoglobin =90 g/L, neutrophil =1.5×10^9/L, platelet count =75×10^9/L;Biochemical test: albumin =28 g/L, total bilirubin =3× upper limit of normal (ULN), aspartate aminotransferase (AST), alanine aminotransferase (ALT)=5×ULN, alkaline phosphatase (ALP)=5×ULN, creatinine =1.5×ULNInternational Standardized ratio (INR) or prothrombin time (PT) =1.5×ULN, activated partial thromboplastin time (APTT) =1.5×ULN; (11) Have a record of hepatitis virological status, confirmed by serological testing for hepatitis B virus (HBV) and hepatitis C virus (HCV).Patients with active HBV received anti-HBV therapy for at least 14 days prior to initiation of attilizumab + bevacizumab therapy and were willing to continue anti-HBV therapy during the study. (12) Women of reproductive age should have a negative serum or urine pregnancy test within 14 days prior to inclusion in the study, must be non-lactating women, and patients should consent to the use of contraceptives during medication and for 60 days after the end of medication; (13) The subjects had good compliance and cooperated with follow-up
Exclusion criteria
Exclusion criteria: (1) There are other primary malignant tumors; (2) Evidence of EHS is confirmed by CT and/or MRI scans of the chest, abdomen and pelvis (3) There is clinically significant ascites; (4) Have a history of hepatic encephalopathy; (5) A history of idiopathic pulmonary fibrosis, institutional pneumonia (such as bronchiolitis obliterans), drug-induced pneumonia, or idiopathic pneumonia, or evidence of active pneumonia on chest CT scan at screening. (6) Severe infection within 4 weeks, including but not limited to hospitalization due to infection complications, bacteremia, or severe pneumonia (7) A history of hypertensive crisis or hypertension, major cardiovascular disease (such as New York Heart Society Class II or worse heart disease, myocardial infarction, or cerebrovascular accident), unstable arrhythmia, or unstable angina in the 3 months prior to initiation of study treatment. Inadequate control of arterial hypertension (defined as systolic blood pressure (BP) =150 mmHg and/or diastolic blood pressure >100 mmHg) (based on the average of =3 BP readings obtained from =2 measurements) - allows the above parameters to be achieved through the use of antihypertensive therapy. (9) Have had serious vascular disease within six months (e.g. aortic aneurysm requiring surgical repair or recent history of peripheral autoimmune disease or immune deficiency),Including, but not limited to, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antilecipid antibody syndrome, Wegener granulomatosis, Sjogren's syndrome, Guillain-Barre syndrome, or arterial thrombosis in multiple sclerosis); (10) Contraindicated use of investigational drugs, any other disease, metabolic dysfunction, physical examination findings, or clinical laboratory findings that may affect the interpretation of results or may place the patient at high risk of treatment complications (11) Systemic immunosuppressive drugs (including, but not limited to, glucocorticoids, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor-a [TNF-a] preparations) were used within 2 weeks or were expected to be required during the study therapy (12) Evidence of bleeding tendencies or severe clotting disorders
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of surgical treatment for liver cancer;Biomarkers for predicting the effectiveness of conversion therapy; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival (OS);Progression-free survival (PFS);Complete response (CR);Partial response (PR);Stable disease (SD);Progressive disease (PD);Objective response rate (ORR);Disease control rate (DCR); | — |
Countries
China
Contacts
Public ContactXinhua Zhu
Department of Hepatobiliary Surgery, the Afliated Drum Tower Hospital of Nanjing University Medical School
Outcome results
None listed