liver cancer
Conditions
Interventions
Experimental group:Sintilimab in the treatment of advanced primary liver cancer
Sponsors
The Second Affiliated Hospital of Harbin Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Hepatocellular carcinoma confirmed by histology/cytology, or liver cirrhosis meets the clinical diagnostic criteria of the American Association for the Study of Liver Diseases (AASLD) for hepatocellular carcinoma. 2. Aged >= 18 years, gender is not limited. 3. Physical condition (ECOG) score of 0 or 1. 4. Barcelona Clinic Liver Cancer (BCLC) stage is C stage or B stage that is not suitable for radical surgery and/or local therapy. 5. Have not received systemic anti-tumor therapy for hepatocellular carcinoma before the first administration (enrollment is allowed for more than 6 months after the end of postoperative adjuvant chemotherapy). 6. According to the Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST V1.1), at least one measurable lesion, or a measurable lesion with definite progression after local therapy (based on RECIST V1.1 criteria). 7. Child-Pugh score =1.5x10^9/L; platelet count (PLT) >=75x10^9/L; hemoglobin content (hemoglobin, HGB) >= 9.0 g/dL. (2) Liver function: serum total bilirubin (TBIL) =28 g/L; alkaline phosphatase (ALP)= 50mL/min (Cockcroft-Gault formula); urine routine results show urine protein =2+ at baseline, 24-hour urine collection should be performed and 24-hour urine protein quantification should be less than 1 g. (4) Coagulation function: International normalized ratio (INR) and activated partial thromboplastin time (APTT) <= 1.5 times ULN. 9. The blood or urine pregnancy test of female patients of childbearing age is negative. 10. All patients have no reproductive plan within 3 years from the beginning of the experiment to the end, and both husband and wife take absolute contraceptive measures. 11. The patients participated voluntarily and signed the informed consent.
Exclusion criteria
Exclusion criteria: 1. Patients with unstable blood sugar control. 2. Those with a history of thrombosis with significant symptoms. 3. Previously diagnosed histologically/cytologically containing fibrous lamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, cholangiocarcinoma and other components. 4. Have a history of hepatic encephalopathy, or a history of liver transplantation. 5. Pleural effusion, ascites, and pericardial effusion with clinical symptoms requiring drainage. 6. Acute or chronic active hepatitis B or hepatitis C infection, hepatitis B virus (HBV) DNA> 2000IU/ml or 10^4 copies/ml; hepatitis C virus (HCV) RNA > 10^3 copies/ml; both hepatitis B surface antigen (HbsAg) and anti-HCV antibodies were positive. 7. Those who have used antiemetics within 24 hours or have vomiting due to various reasons before the first chemotherapy, such as those with gastrointestinal obstruction. 8. Hemorrhage from esophageal or gastric fundus varices caused by portal hypertension in the past 6 months. Known endoscopic presence of severe (G3) varicose veins within 3 months prior to the first dose. Evidence of portal hypertension (including splenomegaly on imaging) and a high risk of bleeding as assessed by the investigator. 9. Any life-threatening bleeding events within the past 3 months, including the need for blood transfusion therapy, surgery or local therapy, and continuous drug therapy. 10. The tumor thrombus of the main portal vein simultaneously involves the contralateral portal vein branches, or simultaneously involves the superior mesenteric vein; tumor thrombus of the inferior vena cava. 11. Within 2 weeks before the first dose, use aspirin (> 325 mg/day) or other drugs known to inhibit platelet function such as dipyridamole or clopidogrel for 10 consecutive days. 12. Uncontrolled hypertension, systolic blood pressure > 140 mmHg or diastolic blood pressure >90 mmHg after best medical treatment, history of hypertensive crisis or hypertensive encephalopathy. 13. Symptomatic congestive heart failure (New York Heart Association class II-IV). Symptomatic or poorly controlled cardiac arrhythmias. History of congenital long QT syndrome or screen-adjusted QTc >500 ms (calculated using the Fridericia method). 14. Severe bleeding tendency or coagulation dysfunction, or receiving thrombolytic therapy. 15. History of gastrointestinal perforation and/or fistula within the past 6 months, history of intestinal obstruction (including incomplete intestinal obstruction requiring parenteral nutrition), extensive bowel resection (partial colectomy or extensive small bowel resection with chronic diarrhea), Crohn's disease, ulcerative colitis, or long-term chronic diarrhea. 16. Received radiation therapy within 3 weeks before the first dose. For patients receiving radiation therapy 3 weeks prior to the first dose, all of the following conditions must be met for enrollment: at present, there is no radiotherapy-related toxicity, no need to take glucocorticoids, and radiation pneumonitis, radiation hepatitis, radiation enteritis, etc. are excluded. 17. Past and current history of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, drug-related pneumonia, severely impaired lung function and other pulmonary diseases. 18. Active pulmonary tuberculosis (TB), who are receiving anti-tuberculosis treatment or who have received anti-tuberculosis treatment within 1 year before the first dose. 19. Human immunodeficiency virus (HIV) infection (HI
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response Evaluation Criteria in Solid Tumors; | — |
Countries
China
Contacts
Public ContactLi Li
Outcome results
None listed