Hepatocytomal carcinoma
Conditions
Interventions
Experimental group:sintilimab + lenvatinib
Sponsors
Shandong Cancer Hospital and Institute, Shandong First Medical University and Shandong Academy of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: Subjects need to meet the following inclusion criteria: 1. Sign written informed consent before any trial-related procedures are implemented 2. Male or female =18 years old 3. ECOG PS score is 0-1 4. Treatment-na?ve advanced/unresectable HCC patients 5. BCLC stage B (not applicable to transarterial chemoembolization)/C stage 6. Child-Pugh Score A 7. At least 1 measurable lesion according to mRECIST criteria 8. Total triiodothyronine (T3) or free T3 and free thyroxine (T4) within normal limits. (Control by thyroid replacement therapy is acceptable). Asymptomatic T3, free T3 or free Subjects with abnormal T4 can be enrolled 9. Adequate blood pressure control 10. 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 ),details as follows ? Blood routine: absolute neutrophil count (ANC) = 1.5×10^9/L, platelet (PLT) =75×10^9/L, hemoglobin (HGB) =90 g/L (no blood transfusion or no erythropoietin dependence within 14 days) ? Liver function: Serum total bilirubin (TBIL) = 2 times the upper limit of normal (ULN); alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) = 5 times ULN, serum white Protein =28 g/L; alkaline phosphatase (ALP) =5×ULN. ? Renal function: Serum creatinine (Cr) = 1.5×ULN, or creatinine clearance = 50 mL/min (using standard Cockcroft-Gault formula): Urine routine results show urine protein <2+; Patients with urine protein =2+ should have 24-hour urine collection And 24-hour urine protein quantification <1g. ? Coagulation function: International normalized ratio (INR) or prothrombin time (PT) = 1.5 times ULN; if the subject is receiving anticoagulation, as long as the INR is within the intended range of anticoagulant use 11. For female subjects of childbearing potential, a negative urine or serum pregnancy test should be performed 3 days prior to receiving the first dose of study drug 12. The subject and the subject's sexual partner need to use a medically approved contraceptive method (such as an intrauterine device, contraceptives or condoms, etc.) during the study treatment period and within 6 months after the end of the study treatment period
Exclusion criteria
Exclusion criteria: Subjects cannot have any of the following exclusion criteria: 1. Previously diagnosed histologically/cytologically containing fibrolamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, cholangiocarcinoma and other components 2. A history of hepatic encephalopathy, or a history of liver transplantation 3. Pleural effusion, ascites, and pericardial effusion with clinical symptoms requiring drainage 4. Acute or chronic active hepatitis B or 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 are positive 5. Has central nervous system metastasis 6. 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 imaging findings of splenomegaly), those at high risk of bleeding as assessed by the investigator 7. Any life-threatening bleeding events within the past 3 months, including the need for blood transfusion therapy, surgery or local therapy, continuous drug therapy 8. 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 9. The tumor thrombus of the main portal vein involves the branches of the portal vein at the same time, or the superior mesenteric vein at the same time. inferior vena cava tumor thrombus 10. 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 11. Uncontrolled hypertension, systolic blood pressure >150mmHg or diastolic blood pressure >90 after optimal medical treatment mmHg, history of hypertensive crisis or hypertensive encephalopathy 12. 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 > 500 ms (use Fridericia method) 13. Severe bleeding tendency or coagulation disorder, or receiving thrombolytic therapy 14. 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 15. 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. 16. Past and current history of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, drug-related pneumonia, severely impaired lu
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dose-limiting toxicity; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate;Progression-free survival;Duration of remission;Disease control rate; | — |
Countries
China
Contacts
Public ContactZuoxing Niu
Outcome results
None listed