Hepatocellular Carcinoma
Conditions
Interventions
Case series:HAIC+Sintilimab+Sorafenib
Sponsors
Department of interventional therapy, cancer hospital, Chinese Academy of Medical Sciences
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients aged 18 to 75 years; 2. Patients who meet the clinical diagnostic criteria of American Association for the study of liver diseases (AASLD) or who have been confirmed by histology / cytology; 3. Patients with a single tumor with a diameter of > 5cm, two to three tumors with a diameter of > 3cm, or more than three tumors; 4. Child Pugh score: Grade A or better grade B (= 7 points); 5. PS score: 0-1; 6. Patients with portal vein invasion or extrahepatic metastasis on baseline imaging; 7. Patients who had not received local anti-tumor treatment for HCC within 4 weeks before admission; 8. Patients who have not received systemic anti-tumor therapy for HCC before; 9. Patients with measurable lesions in line with mrecist standard on baseline imaging; 10. The laboratory test values within 7 days before enrollment meet the following requirements: (1) Absolute neutrophil count (ANC) >=1.5x10^9/L; (2) Platelet count (PLT) >100x10^9/L; (3) Hemoglobin (Hgb) >=9.0 g/dl; (4) Total bilirubin (TBIL) was less than 2 ULN; (5) Alanine aminotransferase (ALT) was less than 5 ULN; (6) Aspartate aminotransferase (AST) =28 g/L; (8) Alkaline phosphatase (ALP) =50ml/min (Cockcroft Gault formula); (10) The results of routine urine test showed that urinary protein was less than 2 +; for patients with routine urine test showed that urinary protein was more than 2 + at baseline, 24-hour urine collection and 24-hour urine protein quantification should be less than 1G; (11) International standard ratio (INR) or activated partial thromboplastin time (APTT) <=1.5 ULN. 11. For women of childbearing age or male patients whose sexual partners are women of childbearing age, effective contraceptive measures should be taken during the whole treatment period and 6 months after the last medication; 12. Patients who can sign the written informed consent and comply with the visit and related procedures specified in the program.
Exclusion criteria
Exclusion criteria: 1. Patients with known history of allogeneic organ or allogeneic hematopoietic stem cell transplantation; 2. Patients with any active autoimmune disease or history of autoimmune disease; 3. HBV DNA > 2000 IU / ml or 104 copies / ml; HCV RNA > 103 copies / ml; HBsAg and anti HCV antibody were positive at the same time; 4. People with HIV infection (HIV 1 / 2 antibody positive); 5. Patients who have been diagnosed with any other malignant tumor (excluding radical skin basal cell carcinoma, skin squamous cell carcinoma or radical resection of carcinoma in situ); 6. Patients with any life-threatening bleeding event within 6 months before enrollment; 7. Patients with thromboembolism of artery and vein within 6 months before admission; 8. There is a high risk of bleeding, including: (1) In the first 30 days, the patients had major trauma or operation; (2) There are any bleeding diseases, such as hemophilia, vascular hemophilia, etc; (3) They are undergoing thrombolysis, anticoagulation or antiplatelet therapy; 9. Patients with symptomatic congestive heart failure (New York Heart Association class II-IV), symptomatic or poorly controlled arrhythmia, history of congenital long QT syndrome or QTc corrected at screening > 500ms, and history of uncontrolled hypertension or hypertensive crisis or hypertensive encephalopathy; 10. Patients with previous and current pulmonary fibrosis history, interstitial pneumonia, pneumoconiosis, drug-related pneumonia, severe impairment of lung function and other lung diseases; 11. Patients with severe infection in active period or poor clinical control or with severe infection within 4 weeks before enrollment; 12. Patients who had used immunosuppressive drugs (excluding local glucocorticoids or systemic glucocorticoids of physiological dose, i.e. < 10 mg / day prednisone or other glucocorticoids of equivalent dose) within 4 weeks before enrollment; 13. Pregnant and lactating women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-Free Survival (PFS); | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease Control Rate (DCR) ;Objective Response Rate (ORR);Duration of Response (DOR);Overal Survival (OS);Safety; | — |
Countries
China
Contacts
Public ContactYang Zhengqiang
Department of Interventional Therapy, Cancer Hospital, Chinese Academy of Medical Sciences
Outcome results
None listed