Liver cancer
Conditions
Interventions
Sponsors
Chinese People's Liberation Army (PLA) General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Obtain informed consent signed by the patient or his or her legal agent; 2. Compliance with the study plan and follow-up procedure; 3. Aged 18 to 70 years old male and female; 4. No surgical contraindications, able to tolerate radical surgery, ECOG behavioral status score 0-1, life expectancy = 12 weeks, ASA score = 2. Inclusion criteria related to disease: 5. Diagnosed as hepatocellular carcinoma preoperatively according to clinical symptoms, imaging examination, tumor markers and other auxiliary examinations and postoperative pathology; 6. HBsAg positive and HBV-DNA positive, without antiviral treatment (guidelines for the prevention and treatment of chronic hepatitis B (2015 edition)); 7. Barcelona clinical liver cancer (BCLC) stage 0, stage A, stage B, no extrahepatic metastasis and macrovascular invasion; 8. According to the diagnosis and treatment specifications for primary liver cancer (2017 edition), preoperative assessment of radical resection of the tumor is as follows: 1) No visual obstruction in hepatic vein, portal vein, bile duct and inferior vena cava; 2) invasion of adjacent organs, no hilar lymph node or distant metastasis; 3) liver resection margin from tumor boundary >1cm, or R0 resection; 4) ultrasonography, CT and MRI were performed 2 months after surgery, and no tumor lesions were found; 5) AFP was elevated before operation and quantitatively measured at 2 months after operation, and its level was in the normal range. Hematology, biochemistry and organ function: 9. Hemoglobin = 9.0 g/dL (this level can be maintained or exceeded by transfusion); 10. Absolute count of neutrophils = 1.5 x 10^9/L; 11. Platelet count = 50 × 10^9/L; 12. Liver function child-pugh graded a-b; 13. creatinine = 1.25 times upper limit of the normal value; The clearance rate of creatinine = 60mL/min. 14. The internationally standardized ratio (INR) of prothrombin time = 1.5 for patients who have not received anticoagulation therapy, and APTT = 1.5 times the upper limit of normal value. Patients receiving full doses or treatment with parenteral anticoagulants are admitted to clinical trials as long as the doses of anticoagulants are stable for at least 2 weeks before entering the clinical study, and the results of the coagulation test are within the limits of local treatment; 15. Women of reproductive age (15 to 49 years old) must undergo a urinary pregnancy test within 7 days before treatment and the results are negative.
Exclusion criteria
Exclusion criteria: 1. Malignant tumors in other areas within the last 5 years; Patients with brain, lung, bone metastases or abdominal lymph node metastases; 2. Antiviral treatment with any drug before this trial; 3. Patients who are participating in other clinical trials; 4. Abnormal ECG or clinically significant heart disease such as congestive heart failure, symptomatic coronary heart disease, arrhythmia, clinically significant heart disease, or myocardial ischemia in the past 12 months; Severe infection, sepsis, severe metabolic disorders or diabetes; Those who need treatment during active period of peptic ulcer, those who have difficulty in absorption, and those who damage the integrity of upper digestive tract; 5. Patients who have a history of allergies to research drugs or similar structures; 6. Women during pregnancy or lactation; 7. Any condition that may compromise patient safety or research data integrity, including serious medical risk factors, medical conditions, and laboratory abnormalities; 8. Infection of HCV, HIV, syphilis; 9. Clinically significant mental abnormalities, a history of central nervous system abnormalities or a history of seizures; 10. The investigator considers it inappropriate to participate in this study; 11. Patients who are unwilling or unable to comply with the study, or may withdraw for one course or more during the treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Biochemical response;Virological response; | — |
Secondary
| Measure | Time frame |
|---|---|
| overall survival;disease-free survival; | — |
Countries
China
Contacts
Public ContactHu minggen
Chinese People's Liberation Army (PLA) General Hospital
Outcome results
None listed