hepatocellular carcinoma
Conditions
Interventions
untreated patients with advanced hepatocellular carcinoma:HIAC plus sintilimab and bevacizumab
Sponsors
Eastern Hepatobiliary Surgery Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Signed written informed consent prior to the implementation of any trial-related procedures 2. Aged 18-70 3. The ECOG PS score is 0-1 4. The patient was initially diagnosed with hepatocellular carcinoma according to the diagnostic criteria of China's Guidelines for the Diagnosis and Treatment of primary liver Cancer (2022 edition) 5. Barcelona Clinic Liver Cancer (BCLC) is stage B and C 6. No previous systemic antitumor therapy for hepatocellular carcinoma 7. Child-pugh Grade A 8. Expected survival time >3 months; 9. At least 1 measurable lesion according to RECIST1.1 criteria 10. Total triiodothyronine (T3) or free T3 and free thyroxine (T4) were within normal limits. (It can be controlled with thyroid replacement therapy). Subjects with asymptomatic T3, free T3, or abnormal free T4 were eligible 11. Get your blood pressure under control 12. With adequate organ and bone marrow function, laboratory test values within 7 days before randomization meet the following requirements (no blood components, cell growth factors, albumin and other corrective treatment drugs are allowed to be given within 14 days before obtaining laboratory tests), as follows: 1) Blood routine: Absolute neutrophil count (ANC) =1.5×109/L; Platelet count (PLT) =50×10 9/L; Hemoglobin (HGB) =9.0 g/dL; 2) Liver function: total bilirubin (TBIL) =3× upper limit of normal value (ULN); Alanine aminotransferase (ALT), aspartate transferase (AST) and alkaline phosphatase (ALP) =5×ULN; Serum albumin =28 g/L; 3) renal function: the serum creatinine (Cr) = 1.5×ULN or the clearance of creatinine (CCr) = 50mL/min (Cockcroft-gault formula); Urine routine results showed urinary protein <2+; For patients with urinary protein =2+ at baseline, 24-hour urine collection and 24-hour urinary protein quantification <1g should be performed. 4) Coagulation function: International Normalized ratio (INR) and activated partial thromboplastin time (APTT) = 1.5 times ULN 13. For female subjects of reproductive age, a negative urine or serum pregnancy test should be performed within 3 days prior to the first study drug administration (day 1 of cycle 1). If the urine pregnancy test result cannot be confirmed as negative, a blood pregnancy test is requested. Women who were not of childbearing age were defined as women who had been postmenopausal for at least 1 year or had undergone surgical sterilization or hysterectomy; 14. If there is a risk of conception, all subjects (male or female) will be required to use contraception with an annual failure rate of less than 1% for the entire treatment period until 120 days after the last study drug administration of treatment (or 180 days after the last chemotherapy drug administration). The expected survival time was =12 weeks
Exclusion criteria
Exclusion criteria: 1. Previous histological/cytological diagnosis of fibrolamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, cholangiocarcinoma, etc 2. A history of hepatic encephalopathy or liver transplantation 3. Hydrothorax, ascites and pericardial effusion with clinical symptoms requiring drainage 4. Patients with acute or chronic active hepatitis B or C with hepatitis B virus (HBV) DNA > 2000IU/ml or 104 copies /ml; HCV RNA > 103 copies /ml; Hepatitis B surface antigen (HbsAg) and anti-HCV antibody were positive simultaneously 5. Central nervous system metastases 6. Bleeding events of oesophagal or gastric fundus varices caused by portal hypertension occurred in the previous 6 months. Severe (G3) varicose veins were known to be present on endoscopy 3 months before the first dose. Patients with evidence of portal hypertension (including splenomegaly on imaging) and a high risk of bleeding as assessed by the investigator 7. Any life-threatening bleeding event in the previous 3 months, including the need for blood transfusion therapy, surgical or local treatment, and continuous medication 8. A history of arteriovenous thromboembolic events within the previous 6 months, including myocardial infarction, unstable angina pectoris, cerebrovascular accident or transient ischemic attack, pulmonary embolism, deep vein thrombosis, or any other major thromboembolism. Implantable venous port or catheter-derived thrombosis, or superficial venous thrombosis, except for thrombus stabilization after routine anticoagulant therapy. Prophylactic use of low-dose LMWH (e.g., enoxaparin 40 mg/ day) is permitted. 9. Aspirin (> 325 mg/ day) or other drugs known to inhibit platelet function, such as dipyridamole or clopidogrel, were administered for 10 consecutive days within 2 weeks before the first dose 10. Uncontrolled hypertension, systolic blood pressure > 150mmHg or diastolic blood pressure > 90 mmHg after optimal medical treatment, history of hypertensive crisis or hypertensive encephalopathy 11. Symptomatic congestive heart failure (New York Heart Association Class II-IV). Symptomatic or poorly controlled arrhythmias. History of congenital long QT syndrome or corrected QTc > 500ms at screening (calculated using Fridericia method) 12. Severe bleeding tendencies or coagulopathy, or undergoing thrombolytic therapy 13. A history of gastrointestinal perforation and/or fistula within the previous 6 months, a history of intestinal obstruction (including incomplete intestinal obstruction requiring parenteral nutrition), extensive bowel resection (partial colectomy or extensive bowel resection with chronic diarrhoea), Crohn's disease, ulcerative colitis, or prolonged chronic diarrhoea 14. Had received radiation therapy within 3 weeks before the first dose. Patients who received radiotherapy 3 weeks before the first dose had to meet all the following criteria to be included in the study: no current radiotherapy-related toxicity, no need for glucocorticoids, and exclusion of radiation pneumonitis, radiation hepatitis, and radiation enteritis 15. Previous or current history of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, drug-related pneumonia, severe impairment of pulmonary function and other lung diseases 16. Persons with active tuberculosis (TB) who are receiving anti-TB therapy or who have received anti-TB therapy within 1 year prior to the first dose 17. People with human immunodef
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| objective response rate;disease control rate;event-free survival;Surgical conversion rate;pathologic complete response;overall survival;safety; | — |
Countries
China
Contacts
Public ContactHaibin Zhang
Eastern Hepatobiliary Surgery Hospital
Outcome results
None listed