Primary hepatocellular carcinoma
Conditions
Interventions
Group PLASCE-II:Laparoscopic or open lateral portal vein ligation (PVL) was performed, and FOLFOX-HAIC regimen was administered 2 weeks after surgery, 200 mg carrilizumab for injection, intravenous in
Group ALPPS:ALPPS was performed laparoscope or laparotomy, and carrilizumab 200 mg intravenously, D1, every 3 weeks (Q3W), combined with Apatinib 250 mg orally, once daily (QD), was given 4-8 weeks po
Sponsors
The First Affiliated Hospital of Guangxi Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. male or female, age: >= 18 years old; 2. Hepatocellular carcinoma was confirmed by histopathology/cytology or was clinically diagnosed as hepatocellular carcinoma according to the Guidelines for the Diagnosis and Treatment of Primary Liver Cancer (2024 edition); 3. Strictly in line with normal liver function (Child-Pugh grade A, ICG-R15= 90 g/L; b) ANC >= 1.5×109/L; c) PLT >= 50×109/L; (2) Biochemical examination: a) ALB >= 28 g/L; b) ALT and AST< 5.0×ULN; c) TBIL <= 3×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) 8. Women of childbearing age must undergo a pregnancy test within 7 days prior to enrollment, with a negative result. Male and female patients of reproductive age agree to abstain from sex (abstain from heterosexual intercourse) or use a reliable, effective contraceptive method before and during study participation and for at least 120 days after withdrawal; 9. Subjects voluntarily joined the study, signed informed consent, had good compliance, and cooperated with follow-up.
Exclusion criteria
Exclusion criteria: 1. Known hepatobiliary duct cell carcinoma, mixed cell carcinoma and fibrolaminar cell carcinoma; Previous (within 5 years) or concurrent with other uncured malignancies, except for cured basal cell carcinoma of the skin and carcinoma in situ of the cervix. 2. There are tumors in the left and right liver that cannot be radically resected; There were cancer thrombus in the left and right branches of portal vein. Main portal vein or inferior vena cava cancerous thrombus. 3. Patients preparing for liver transplantation (except those who have previously undergone liver transplantation); Patients with extrahepatic metastasies, severe liver function impairment [Child-Pugh grade B/C and/or ICG-R15>20%], complicated with severe portal hypertension, complicated with severe cirrhosis, generally poor condition, unable to tolerate major surgery, and with serious underlying diseases, unable to tolerate anesthesia. 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 III ~ IV cardiac insufficiency or heart color ultrasound examination: LVEF (left ventricular ejection fraction) = (++) shall not be included in the group; If there is occult blood in the stool (+), gastroscopy is required. 10. Had an abdominal fistula, gastrointestinal perforation, or abdominal abscess in the 28 days prior to enrollment in the study. 11. Abnormal coagulation function (INR > 2×ULN or prothrombin time (PT) > ULN+4 seconds), bleeding tendency or receiving thrombolytic or anticoagulant therapy. 12. Autoimmune diseases, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid antibody syndrome, Wegener's granuloma, Sjogren's syndrome, Guillain-Barre syndrome, or multiple sclerosis. 13. Patients with prior or current objective evidence of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonia, drug-related pneumonia, and 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 with HIV infection.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1-year event-free survival rate;Incidence of postoperative complications = grade III; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival;Event-free survival;Disease-free survival;conversion resection rate;safety; | — |
Countries
China
Contacts
Public ContactTao Peng
The First Affiliated Hospital of Guangxi Medical University
Outcome results
None listed