hepatocellular carcinoma
Conditions
Interventions
Cardunizumab group (A):cardonilizumab for neoadjuvant therapy with sequential hepatectomy
cardonilizumab combined with HAIC group(B):cardonilizumab combined with HAIC for neoadjuvant therapy with sequential hepatectomy
HAIC group(C):HAIC for neoadjuvant therapy with sequential hepatectomy
Sponsors
The First Affiliated Hospital of Guangxi Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1: Subjects volunteered to participate in the study, signed the informed consent, had good compliance, and cooperated with follow-up. 2: Age: 18 ~ 75 years old, no gender requirement 3: Histologically, cytologically or imageologically documented hepatocellular carcinoma 4: resectable CNLC?b/?a multinodular hepatocellular carcinoma 5: Patients has not received systematic therapy for hepatocellular carcinoma, including chemotherapy, targeted therapy, immunotherapy, etc. Patients who had previously received local radical surgery or ablation were admitted, except those who had relapsed within 2 years after radical surgery or other local treatments 6: no contraindications to HAIC therapy 7: Child-Pugh grade A 8: eastern cooperative oncology group-performance status (ECOG-PS) score: 0-1 9: Predicted life expectancy of = 12 weeks 10: Hepatitis B virus (HBV) infection: If serum HBsAg positive, HBV-DNA testing should be less than 2000000 IU/mL, and anti-HBV therapy is needed at least 1 week prior to randomization. Besides, patients should have willingness to receive antiviral therapy throughout the study period. Patients with positive serum hepatitis C virus (HCV) -RNA must receive antiviral therapy according to related guidelines. 11: the major organs are functioning normally, the following criteria are met: 1. blood routine examination(Except for Hb, there was no blood transfusion, no granulocyte colony stimulating factor, and no drug to rectify within 2 weeks prior to screening): a) Hb= 90 g/Lb) ANC= 1.5×109/Lc) PLT= 75×109/LBlood biochemical examination: a) ALB= 29 g/L, b) ALT and AST 50 ml/min, e) INR =1.2 or PT exceeding the normal control range = 2 seconds, f) Urine protein < 2+ (if urine protein = 2+, 24 hours (h) urine protein quantification can be performed, 24 hours (h) urine protein quantification < 1.0g can be recruited) 12: Only one of the albumin and bilirubin term can be a score of 2 in the Child-pugh grade scoring 13: For women of childbearing potential, must agree to remain abstinent or use a reliable and effective method of contraception for at least 120 days from the date of signing the informed consent until the final therapy. Serum HCG must be negative within 72 hours before randomization. And it must be non-lactation. A woman is considered fertile if she has menstruated, has not reached postmenopausal status (no menstruation for =12 months, no cause other than menopause found), and has not undergone sterilization (such as hysterectomy, bilateral tubal ligation, or bilateral ovariectomy). 14: Male subjects whose partner is a fertile woman must agree to remain abstinent or use a reliable, effective method of contraception for at least 120 days from the date of the informed consent until the final therapy. Male subjects also had to agree not to donate sperm during the aforementioned time period. Male subjects with a pregnant partner are required to use condoms and do not need to use other methods of contraception.
Exclusion criteria
Exclusion criteria: 1: Known intrahepatic cholangiocarcinoma and combined hepatocellular cholangiocarcinoma and fibrolamellar hepatocellular carcinoma. Previous (within 5 years) or co-existing uncured malignancies. 2: If there were clinically significant bleeding symptoms or definite bleeding tendency within 6 months before randomization, such as gastrointestinal bleeding, severe esophageal varicose veins, hemorrhagic gastric ulcer or vasculitis, positive stool occult blood in baseline period could be re-examined. if it was still positive, a gastroscopy should be performed. 3: Ascites with clinical symptoms, that is, therapeutic abdominal puncture or drainage is required. Child-pugh grade> A (7). 4: Patients preparing for liver transplantation (other than those who have previously undergone liver transplantation). extrahepatic metastasies, severe liver function impairment (Child-Pugh grade B/C and/or ICG-R15> 20%), severe portal hypertension, severe cirrhosis, poor general condition which is unable to tolerate major surgery, and severe underlying diseases which is unable to tolerate anesthesia 5: Not well controlled symptoms or disease of cardiovascular system, such as: cardiac insufficiency at II grade assessing by the New York Heart Association (NYHA) criteria or Color Doppler ultrasound ECG: LVEF (left ventricular ejection fraction) 450ms (male) or QTc> 470ms (female). 6: Arterial thromboembolism events, such as cerebrovascular accidents (including temporary ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis with CTCAE grade 3 or above, pulmonary embolism and so forth occurred within 6 months before randomization 7: Patients with hypertension that cannot be controlled to the normal range by antihypertensive medication (systolic blood pressure > 150mmHg, diastolic blood pressure > 90 mmHg (average BP reading based on = 2 measurements). Previous hypertensive crisis or hypertensive encephalopathy 8: underwent a major surgery (except diagnosis) within 4 months before randomization or require a major surgery treatment (except projected hepatectomy) during the study period. 9: severe and unclosed wound and active canker disease or untreated fracture 10: Major vascular disease within 6 months before randomization (e.g., aortic aneurysm requiring surgical treatment or with recent peripheral artery thrombosis) 11: Known hereditary or acquired bleeding (e.g., coagulation disorders) or thrombotic tendencies (e.g., hemophilia, coagulation disorders, thrombocytopenia, etc.) currently receiving full doses of oral or injectable anticoagulants or thrombolytic drugs for therapeutic purposes (excluding prophylactic use of low-dose aspirin, etc.) 12: Patients with previous and current objective evidence of interstitial pneumonia or interstitial lung disease requiring hormone therapy 13: other pulmonary fibrosis, institutionalized pneumonia such as obliterative bronchiolitis, pneumoconiosis, drug-related pneumonia, idiopathic pneumonia, active pneumonia or severe lung function disorder with the possibilities of interfering with the judgment and management of immune-related pulmonary toxicity 14: Known hereditary or acquired bleeding (e.g., coagulation disorders) or thrombotic
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| major pathologic response/major pathologic response ratio;1-year EFS;Incidence and severity of AE; | — |
Countries
China
Contacts
Public ContactTao Peng
The First Affiliated Hospital of Guangxi Medical University
Outcome results
None listed