Liver Cancer
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Aged 18-75 years old; 2. Patients with unresectable hepatocellular carcinoma and intrahepatic cholangiocarcinoma who strictly comply with the clinical diagnostic criteria of "diagnostic and therapeutic criteria for primary liver cancer" (2019 Edition) or confirmed by histopathology or cytology; 3. At least one measurable lesion (according to RECIST version 1.1, the measurable lesion has a long diameter of >= 10 mm or a short diameter of an enlarged lymph node >=15 mm); the largest tumor is less than or equal to 10 cm; 4. Child Pugh liver function rating: A or B grade; 5. BCLC stage was B or C; 6. ECoG PS score: 0-2 points; 7. Expected survival time >=12 weeks; 8. HBV DNA =90 g/L; ANC>=1.5x10^9/L; PLT>=50x10^9/L; (2) Biochemical examination: ALB >=29 g/L; ALT and AST were < 5uln; TBIL <=2 ULN; Creatinine <=1.5 ULN; 10. Women of childbearing age should be given pregnancy test within 7 days before enrollment; 11. The subjects volunteered to join the study, signed the informed consent form, had good compliance and cooperated with the follow-up.
Exclusion criteria
Exclusion criteria: 1. Mixed cell carcinoma and fibrolamellar cell carcinoma; previously (within 5 years) or at the same time suffering from other untreated malignant tumors, except for skin basal cell carcinoma and cervical carcinoma in situ; 2. Patients who are ready for liver transplantation (except those who have received liver transplantation before); 3. Ascites with clinical symptoms need therapeutic abdominal puncture or drainage, or child Pugh score > 2; 4. Patients with hypertension who can not be reduced to normal range after antihypertensive drug treatment (systolic blood pressure > 140 mmHg, diastolic blood pressure > 90 mmHg); 5. Patients with grade II or above myocardial ischemia or myocardial infarction and arrhythmia with poor control (including QTc interval >=450 ms in male and >=470 MS in female); 6. According to NYHA standard, grade III-IV cardiac insufficiency or echocardiography: LVEF =+ +, can not be included in the group; if fecal occult blood (+), gastroscopy is required; 9. Abdominal fistula, gastrointestinal perforation or abdominal abscess occurred within 28 days before the study; 10. Abnormal coagulation function (INR > 1.5 or prothrombin time (PT) > ULN + 4 seconds) with bleeding tendency or undergoing thrombolytic or anticoagulant therapy; 11. Urine routine examination showed urine protein >= + +, or confirmed 24-hour urine protein quantity > 1.0 G; 12. Received strong CYP3A4 inhibitor treatment within 7 days before participating in the study, or received strong CYP3A4 inducer treatment within 12 days before participating in the study; 13. Pregnant or lactating women; fertile patients who are unwilling or unable to take effective contraceptive measures.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy and safety; | — |
Countries
China
Contacts
Affiliated Hospital of Qingdao University