Hepatocellular carcinoma
Conditions
Interventions
combined therapy group:combination of anti-pd-1 / pd-l1 antibody and Lenvastinib
Sponsors
Department of Hepatobiliary Surgery Chinese PLA General Hospital & Medical School
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Sign written informed consent and be able to comply with the visits and related procedures specified in the protocol. 2. Aged >= 18 and = 12 weeks. 10. Female subjects of childbearing age or male subjects whose sexual partners are females of childbearing age should take effective contraceptive measures throughout the treatment period and 6 months after the treatment period. 11. 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 count (PLT) >=50 ×10^9/L; hemoglobin (HGB) >= 8.5 g/dL. Liver function: serum total bilirubin (TBIL) = 28 g/L; alkaline phosphatase (alkaline phosphatase, ALP) = 50 mL/min (Cockcroft-Gault formula); urine routine results show urine protein < 2+. Coagulation function: International normalized ratio (INR) <= 2, and activated partial thromboplastin time (APTT) <= 1.5 times ULN.
Exclusion criteria
Exclusion criteria: 1. Histology includes fibrous lamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, cholangiocarcinoma and other components. 2. A history of hepatic encephalopathy, or a history of liver transplantation. 3. Patients with pleural effusion, ascites, and pericardial effusion with clinical symptoms or needing drainage, only a small amount of pleural effusion, ascites, and pericardial effusion shown by imaging and asymptomatic can be selected. 4. Acute or chronic active hepatitis B or hepatitis C infection, hepatitis B virus (HBV) DNA > 10^6 copies/ml; hepatitis C virus (HCV) RNA> 10^4 copies/ml; and no anti-virus treatment. 5. Symptomatic central nervous system metastases. Patients with asymptomatic brain metastases or patients with stable brain metastases after treatment were eligible to participate in this study as long as they met all of the following criteria: measurable lesions outside the central nervous system; no midbrain, pons, cerebellum, meninges, Medullary or spinal metastases; maintain clinical stability for at least 4 weeks; stop glucocorticoid therapy two weeks before the first dose of study drug. 6. Hemorrhage from esophageal or gastric fundus varices caused by portal hypertension in the past 6 months. Patients with evidence of portal hypertension (including splenomegaly detected by imaging examination) must undergo endoscopy within 3 months, and those with severe varicose veins were not eligible. 7. Any life-threatening bleeding events in the past 3 months, including the need for blood transfusion therapy, surgery or local therapy, and 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 aspirin and low-molecular-weight heparin is allowed. 9. Uncontrolled hypertension, systolic blood pressure >= 150mmHg or diastolic blood pressure >= 100mmHg after optimal medical treatment, history of hypertensive crisis or hypertensive encephalopathy. 10. Symptomatic congestive heart failure (New York Heart Association class II-IV). Symptomatic or poorly controlled cardiac arrhythmias. QT interval prolongation, QTc > 450ms (male), QTc > 470ms (female). 11. Severe bleeding tendency or coagulation dysfunction, or receiving thrombolytic therapy. 12. History of gastrointestinal perforation and/or fistula within the past 6 months, history of intestinal obstruction (including incomplete intestinal obstruction requiring parenteral nutrition), inflammatory bowel disease or extensive bowel resection (partial colectomy or extensive small bowel resection) , complicated by chronic diarrhea), Crohn's disease, ulcerative colitis, or chronic diarrhea. 13. History of interstitial pneumonia, drug-induced pneumonia, idiopathic pneumonia or active pneumonia. Radiation pneumonitis within the radiotherapy area is allowed. 14. Active pulmonary tuberculosis (TB), who are receiving anti-tuberculosis treatment or who have received anti-tuberculosis treatment within 1 year before the first study drug. 15. Human immunodeficiency virus (HIV) infection (HIV 1/2 antibody positive). 16. Active or clinically poorly controlled serious i
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| conversion rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| objective response rate, ORR;Overall Survival, OS;6-month Recurrence-Free Survival Rate;Pathological response;R0 resection rates; | — |
Countries
China
Contacts
Public ContactLu Shichcun
Chinese PLA General Hospital & Medical School
Outcome results
None listed