Hepatocellular carcinoma
Conditions
Interventions
Treatment group:Tislelizumab Injection combined with oral AGU
Sponsors
The First Affiliated Hospital of Guangxi Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: To be eligible for the trial, subjects must meet all of the following inclusion criteria: 1. Voluntarily participated in this study, signed the informed consent form (ICF), with good compliance, and cooperated with follow-up; 2. Age of 18-75 years old, male or female; 3. Hepatocellular carcinoma confirmed by histopathology, cytology, or imaging; 4. Patients with hepatocellular carcinoma who were considered amenable to radical surgery by MDT discussion; 5. CNLC stage IIa-IIb 6. Microvascular invasion 7. No previous systemic treatment for hepatocellular carcinoma, including chemotherapy, targeted therapy, immunotherapy, etc. Patients who had undergone previous curative surgery were allowed, except those who had a recurrence within 2 years after curative surgery and those who had received other previous local treatments. 8. At least one measurable lesion according to Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST V1.1); 9. Child-Pugh liver function: grade A (=6 points); 10 ECOG PS score: 0-1; 11. Expected survival time >= 12 weeks; 12. If a patient has HBV or HCV infection, the following conditions must be met: (1) Patients with detectable hepatitis B surface antigen (HBsAg) or detectable HBV DNA should be treated with antiviral therapy according to the guidelines, and there is a significant downward trend. Patients receiving antiviral therapy at screening should have been treated for >2 weeks before screening and continued for the duration of the study. (2) For subjects infected with HCV, infection was defined as detectable HCV RNA, and patients should receive continuous and effective antiviral therapy for the duration of the study. 13. Adequate organ and bone marrow function with laboratory values within 7 days prior to enrollment (no blood components, cell growth factors, albumin, or other corrective medications were allowed within 14 days prior to laboratory testing), as follows: (1) Blood routine: absolute neutrophil count (ANC) >=1.5×109/L; platelet count (PLT)>=75×109/L; hemoglobin (HGB) level >=9.0 g/dL. (2) Liver function: total bilirubin (TBIL) =28 g/L; alkaline phosphatase (ALP) =50mL/min(Cockcroft-Gault formula); Urine routine results showed that urine protein was less than 2+. Patients with a urine protein level of 2+ or more on routine urinalysis at baseline should undergo a 24-hour urine collection with a 24-hour urinary protein quantification of less than 1g. (4) Coagulation: international normalized ratio (INR) and activated partial thromboplastin time (APTT) =12 months of continuous absence of menses, with no cause other than menopause identified), and had not undergone sterilization procedures (e.g.,
Exclusion criteria
Exclusion criteria: Subjects were not included in the study if they met any of the following conditions: 1. Known intrahepatic cholangiocarcinoma, sarcomatoid hepatocellular carcinoma, mixed cell carcinoma (ICC component > 30%), and fibrolamellar cell carcinoma; Patients with active malignant tumors other than HCC within 5 years or at the same time; 2. Patients with clinically significant bleeding symptoms or clear bleeding tendency within 6 months before enrollment, such as gastrointestinal bleeding, severe esophagogastric varices, hemorrhagic gastric ulcer, or angiitis, if fecal occult blood was positive at baseline, reexamination could be performed. If the reexamination was still positive, gastroscopy was required. 3. Clinically symptomatic ascites requiring therapeutic abdominal paracentesis or drainage, or Child-Pugh score > 7 or history of hepatic encephalopathy; 4. Patients for liver transplantation (excluding patients with previous liver transplantation); Patients with extrahepatic metastasis, severe liver function damage (Child-Pugh class B/C and/or ICG-R15> 20%), severe portal hypertension, severe cirrhosis, poor general condition, and severe underlying diseases who could not tolerate major surgery, and anesthesia; 5. There are uncontrolled cardiac clinical symptoms or diseases, such as: (1) according to the New York Heart Association (NYHA) (see Appendix 3) standard of grade II or higher cardiac dysfunction or color Doppler ultrasound electrocardiogram: LVEF (left ventricular ejection fraction) 450ms (male); QTc> 470ms (female); 6. Arterial thromboembolism events occurred within 6 months before enrollment, such as cerebrovascular accident (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), CTCAE grade 3 or above deep vein thrombosis, pulmonary embolism, etc. 7. Have hypertension that is not well controlled with antihypertensive medication (systolic blood pressure >= 150mmHg or diastolic blood pressure >= 90mmHg; Based on the mean of >= 2 BP readings), allowing for the use of antihypertensive treatment; A history of hypertensive crisis or hypertensive encephalopathy; 8. Received major surgery within 4 weeks before enrollment (except diagnosis) or anticipated need for major surgery during the study period; 9. Severe, unhealed or dehiscence wounds and active ulcer disease or untreated fractures; 10. Major vascular disease (e.g., aortic aneurysm requiring surgical repair or recent peripheral thrombosis) within 6 months before randomization; 11. Known hereditary or acquired bleeding (such as coagulopathy) or thrombophilia, such as in hemophilia patients, coagulation disorders, thrombocytopenia, etc.; Currently receiving full-dose oral or injectable anticoagulant or thrombolytic therapy (prophylactic use, such as low-dose aspirin, was allowed); Aspirin (> 325 mg/ day) or other drugs known to inhibit platelet function such as dipyridamole or clopidogrel were administered for 10 consecutive days within 2 weeks before the first dose. 12. Current interstitial pneumonia or interstitial lung disease, or a previous history of interstitial pneumonia or interstitial lung disease requiring steroid therapy, or other pulmonary fibrosis, organizing pneumonia (e.g., Bronchiolitis obliterans), pneumoconiosis, drug-associated pneumonia,
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Recurrence-Free Survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| 1 year Recurrence-free survival rate;2-year Recurrence-free survival rate;overall survival,OS;Safety and Tolerability; | — |
Countries
China
Contacts
Public ContactPeng Tao
The First Affiliated Hospital of Guangxi Medical University
Outcome results
None listed