Hepatocellular carcinoma
Conditions
Interventions
treatment group:Camrelizumab plus Lenvatinib
Sponsors
the First Affiliated Hospital, Sun Yat-Sen University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Hepatocellular carcinoma confirmed by histology/cytology, or liver cirrhosis meets the clinical diagnostic criteria of American Association for the Study of Liver Diseases; (AASLD) hepatocellular carcinoma; 2. Barcelona Clinic Liver Cancer (BCLC) stage C , B stage not suitable for radical surgery and/or local treatment; 3. Age 18-75 years old; 4. Have not received systemic 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); 5. According to the Response Evaluation Criteria for 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); 6. ECOG score 0-1; 7. Child-Pugh classification of liver function A; 8. Expected survival time >= 3 months; 9. Have sufficient organ and bone marrow function, and the laboratory test values ??within 7 days before enrollment meet the following requirements (no blood components, cell growth factors, albumin and other drugs for corrective treatment are not allowed within the first 14 days of obtaining laboratory tests ), as follows: blood routine: absolute neutrophil count (ANC) >=1.5x10^9/L; platelet count (PLT) >=75x10^9/L; hemoglobin content (hemoglobin) , HGB) >= 9.0 g/dL; liver function: serum total bilirubin (TBIL) =28 g/L; alkaline phosphatase (ALP)= 50mL/min (Cockcroft-Gault formula); urine routine results show urine protein = 2 For patients with +, a 24-hour urine collection should be performed and the 24-hour urine protein quantification should be <1 g.
Exclusion criteria
Exclusion criteria: 1. Previously diagnosed histologically/cytologically containing fibrolamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, cholangiocarcinoma and other components; 2. History of hepatic encephalopathy, refractory ascites or severe gastric fundus esophageal varices, and history of esophageal rupture and bleeding; 3. There is central nervous system transfer; 4. 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; 5. Arterial and venous thromboembolic events within the past 6 months, including myocardial infarction, unstable angina, cerebrovascular accident or transient ischemic attack, pulmonary embolism, deep vein thrombosis or any other history of severe thromboembolism. Implantable venous port or catheter-derived thrombosis, or superficial vein thrombosis, except those with stable thrombus after conventional anticoagulation. Prophylactic use of low-dose low-molecular-weight heparin (eg, enoxaparin 40 mg/day) is permitted; 6. 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; 7. Uncontrolled hypertension, systolic blood pressure >140 mmHg or diastolic blood pressure >90 mmHg after optimal medical treatment, history of hypertensive crisis or hypertensive encephalopathy; 8. Symptomatic congestive heart failure (New York Heart Association class II-IV). Symptomatic or poorly controlled cardiac arrhythmias. History of congenital long QT syndrome or adjusted QTc at screening >500ms (calculated using Fridericia method); 9. 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, complicated by chronic diarrhea) , Crohn's disease, ulcerative colitis, or long-term chronic diarrhea; 10. Received radiation therapy within 3 weeks before the first dose. For patients who received radiation therapy 3 weeks before the first dose, all of the following conditions must be met: there is currently no radiation-related toxicity, no need to take glucocorticoids, radiation pneumonitis, radiation hepatitis, radiation Enteritis, etc.; 11. Past and current history of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, drug-related pneumonia, severely impaired lung function and other pulmonary diseases; 12. Active pulmonary tuberculosis (TB), who are receiving anti-tuberculosis treatment or who have received anti-tuberculosis treatment within 1 year before the first dose; 13. There are contraindications to TACE treatment, such as portosystemic shunt, hepatic blood flow, and obvious atherosclerosis; 14. Human immunodeficiency virus (HIV) infection (HIV 1/2 antibody positive), known syphilis infection; 15. Active autoimmune disease requiring systemic therapy (eg, use of disease-modifying drugs, corticosteroids, or immunosuppressants) within 2 years prior to the first dose. Alternative therapy (eg, thyroxine, insulin, or physiologic cortic
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Survival, OS; | — |
Countries
China
Contacts
Public ContactLi Heping
the First Affiliated Hospital, Sun Yat-Sen University
Outcome results
None listed