Primary hepatocellular carcinoma
Conditions
Interventions
experimental group:Portal vein ligation was performed first, followed by carrilizumab 200mg intravenously, D1, every 14 days (Q2W)
Combined with Apatinib 250mg orally, once a day, continuous administration, 4 weeks as a cycle. Until the termination event specified in the program occurs.
Sponsors
The First Affiliated Hospital of Guangxi Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age: 18-75 years old; 2. Patients with primary hepatocellular carcinoma, who strictly conform to normal liver function (Child-Pugh grade A, ICG-R15<10%), normal liver FLR/SLV < 20% ~ 30%; Patients with chronic liver disease or hepatic parenchymal injury (including cirrhosis, severe fatty liver, and chemotherapy-related liver injury) had FLR/SLV < 40% (standard liver volume SLV: FLR of residual liver volume after surgery). 40 3. ECOG-PS score 41 within 1 week before enrollment: 0-1; 4. BCLC stages A-C; 5. Expected survival =12 weeks; 6. If the major organs function normally, the following criteria are met: (1) Blood routine examination: a) HB=90 g/L; b) ANC=1.5×109/L; c) PLT=80×109/L; (2) Biochemical examination: a) ALB =29 g/L; b) ALT and AST<3.0×ULN; c) TBIL =2×ULN; d) Creatinine =1.5×ULN; (Only one of the two indicators of albumin and bilirubin in the Child-Pugh rating can be 2 points) 7. Women of childbearing age must undergo a pregnancy test within 7 days before enrollment; 8. Subjects voluntarily joined the study, signed informed consent, had good compliance, and cooperated with follow-up.
Exclusion criteria
Exclusion criteria: 1. Patients with known intrahepatic cholangiocarcinoma and mixed hepatocellular carcinoma-cholangiocarcinoma and fibrous lamellar cell carcinoma; previous (within 5 years) or concurrent other uncured malignancies, except for cured basal cell carcinoma of the skin and carcinoma in situ of the cervix. 2. Patients prepared for liver transplantation (except those who have previously undergone liver transplantation); the presence of extrahepatic metastases, severe hepatic impairment [Child-Pugh grade B/C and/or ICG-R15>20%], combined with severe portal hypertension, combined with severe cirrhosis, poor general condition unable to tolerate major surgery, and the presence of severe underlying disease unable to tolerate anesthesia. 3. The presence of tumors both in the right and left liver, tumors that cannot reach radical resection; cancerous thrombosis of the main portal vein or inferior vena cava. 4. Ascites with clinical symptoms, i.e. therapeutic abdominal puncture or drainage, or Child-Pugh score > 7. 5. Patients with hypertension who cannot be reduced to the normal range by antihypertensive medication (systolic blood pressure > 140 mmHg, diastolic blood pressure> 90 mmHg). 6. Patients with grade II or above myocardial ischemia or myocardial infarction and poorly controlled arrhythmias (including QTc interval =450 ms for men and 470 ms for women). 7. According to NYHA standard ? ~ ? cardiac insufficiency or heart color ultrasound examination: LVEF (left ventricular ejection fraction) 1.5 or prothrombin time (PT) > ULN+4 seconds), bleeding tendency or being treated with thrombolytic or anticoagulant therapy. 12. Patients with central nervous system metastases or known brain metastases. 13. Patients with prior or current objective evidence of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonia, drug-related pneumonitis, or severe impairment of lung function. 14. Urine routine showed urinary protein =++ or confirmed 24-hour urinary protein quantity > 1.0g. 15. Received a potent CYP3A4 inhibitor within 7 days prior to study entry or a potent CYP3A4 inducer within 12 days prior to study entry. 16. Pregnant or lactating women; Fertile patients who are unwilling or unable to use effective contraception. 17. Have a history of mental illness or substance abuse. 18. Patients who had developed bone metastases had received palliative radiotherapy (radiotherapy area > 5% of the bone marrow area) in the 4 weeks prior to joining the study. 19. Patients with HIV infection.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1 year event free survival rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival;Objective response rate;Conversion resection rate;Disease-free survival ;Safety; | — |
Countries
China
Contacts
Public ContactPeng Tao, Ma Jie
The First Affiliated Hospital of Guangxi Medical University
Outcome results
None listed