hepatocellular carcinoma
Conditions
Interventions
Test group:Administrating Carilizumab 200mg QD+ Apatinib mesylate tablet 250mgQD 3W
Sponsors
Hunan Provincial Tumor Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age >=18 years old; 2. Patients with clinical or pathological diagnosis of hepatocellular carcinoma; 3. Have not received systemic therapy in the past; 4. Imaging assessment of liver lesions as unresectable and without extrahepatic metastasis: CT and/or MRI were used to measure the remaining liver volume, and the percentage of the remaining liver volume to the standardized liver volume was calculated, and the remaining liver volume accounted for 40% of the standard liver volume. Less than (patients with liver cirrhosis), or less than 30% (patients without liver cirrhosis); 5. BCLC staging: B, C/CNLC IIa, IIb, IIIa; 6. Child-Pugh score A; 7. The retention rate of indocyanine green (ICG) clearance test in 15min is less than 30%; 8. ECOG score: 0-1 points; 9. There is at least one measurable lesion according to the criterion 1.1; 10. Expected survival period >= 3 months; 11. Sign the informed consent form before joining the group.
Exclusion criteria
Exclusion criteria: 1. Patients with any active autoimmune disease or history of autoimmune disease, including but not limited to: hepatitis, pneumonia, metritis, colitis (inflammatory bowel disease), ischemia, vasculitis, nephritis, thyroid function Subjects with hyperthyroidism and hypothyroidism but with albinism or resolved childhood asthma/top tunnel. Asthma requiring intermittent use of bronchodilators or other medical interventions should also be excluded; 2. Diseases that require the use of immunosuppressive drugs, or systemic or absorbable topical corticosteroids at the same time; 3. Known history of hypersensitivity to any component of the SHR-1210 formulation or other antibody formulations; 4. Known or occurred central nervous system (CNS) metastasis or hepatic encephalopathy; 5. Hypertension and antihypertensive drugs that cannot be controlled to normal levels (within 3 months): systolic blood pressure > 140 mmHg, diastolic blood pressure > 90 mmHg; 6. Clinically important cardiovascular and cerebrovascular diseases, including but not limited to severe acute myocardial infarction, unstable or severe angina pectoris within 6 months prior to enrollment, or coronary artery bypass surgery, congestive heart failure (New York Heart Association (NYHA) class > 2), ventricular arrhythmia requiring medical intervention; 7. Abnormal coagulation function (INR>2.0 and/or PT>16s), bleeding tendency or receiving thrombolysis or anticoagulant treatment; 8. Past history of gastrointestinal bleeding within 3 months or obvious gastrointestinal bleeding tendency, such as: esophageal varices, locally active ulcer lesions, gastric and duodenal ulcers, ulcerative colitis, gastrointestinal diseases Such as portal hypertension or tumor resection with risk of bleeding; 9. Anterior arterial/venous thrombosis occurs within 3 months; 10. Proteinuria = (+) and 24-hour total urine protein > 1.0 g; 11. History of immunodeficiency or human immunodeficiency virus (HIV) infection; 12. Patients with other malignant tumors (except for cured skin basal cell carcinoma and cervical cancer); 13. Patient is on prior SHR-1210 or any other PD-L1 or PD-1 antagonist.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate (ORR); | — |
Countries
China
Contacts
Public ContactLuo Jia
Hunan Provincial Tumor Hospital
Outcome results
None listed