Hepatocellular carcinoma
Conditions
Interventions
Experimental group:Hepatic artery infusion of oxaliplatin, oral administration of mHAIC in combination with ranvartinib and carlizumab
Sponsors
The Affiliated Hospital of Yanbian University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Patients must voluntarily participate in this study, sign informed consent, comply well, and cooperate with follow-up; 2. Aged 18-75 years, including 18 and 75 years old; 3. ECOG PS equal 0-2; 4. Cirrhosis without cirrhosis or only Child-Pugh grade A-B cirrhosis; 5. Patients with portal vein invasion; 6. The sum of size and diameter of all lesions was greater than 12; 7. There is at least one measurable lesion in the liver, and intrahepatic tumor is the main tumor load; 8. Surgical excision or local ablation is not possible, or TACE treatment does not benefit; 9. If the major organs are functioning normally, the following criteria are met: (1) Platelet >=50x10^9 / L; (2) Hemoglobin >=90 g/L; (3) Serum albumin >=28 g/L; (4) Absolute neutrophil count >=3.0x10^9 / L; (5) Thyroid stimulating hormone (TSH) <=1xULN (if FT3 and abnormal FT4 levels should be considered at the same time, patients with FT3 and FT4 levels within the normal range can also be recruited); (6) Bilirubin <=1.5xULN (within 7 days before the first dose); (7) ALT<=3 ULN and AST<=3 ULN (within 7 days before the first dose); (8) AKP<=2.5xULN; Serum creatinine <=1.5xULN; 10. Expected survival of more than 12 weeks; 11. Can swallow drugs normally; 12. For non-surgical sterilizations or women of reproductive age, medically approved contraceptives (e.g. intrauterine devices, contraceptives or condoms) must be used during the study period and for three months after the end of the study treatment period; For women of non-surgical sterilization or reproductive age, serum or urine HCG testing must be negative within 72 hours prior to enrollment; And must be non-lactating; For males, they should be surgically sterilized or agree to use an appropriate method of contraception during the trial period and within 3 months after the last administration of the trial drug.
Exclusion criteria
Exclusion criteria: 1. The patient has a history of any active autoimmune disease or autoimmune disease; 2. Patients were taking immunosuppressive agents or systemic hormone therapy for immunosuppressive purposes (prednisone or other therapeutic hormones at doses > 10 mg/day) and continued to use them within 2 weeks prior to enrollment; 3. Severe allergic reactions to other monoclonal antibodies; 4. Patients with central nervous system metastasis or hepatic encephalopathy; 5. Have a history of organ transplantation; 6. Patients with clinically symptomatic ascites need puncture, drainage or ascites drainage within 3 months, except patients with low abdominal water volume but no clinical symptoms; 7. Have high blood pressure that is not well controlled with blood pressure medications (systolic blood pressure >=140mmHg or diastolic blood pressure >=90mmHg); 8. Having clinically symptomatic or poorly controlled heart disease, such as: (1) NYHA grade 2 or higher heart failure;(2) Unstable angina; (3) Myocardial infarction occurred within 1 year; (4) Clinical symptomatic supraventricular or ventricular arrhythmias require treatment or intervention; (5) QTc> 450ms (male); QTc> 470ms (female); 9. Cotting dysfunction (INR> 2.0, PT> 16s), bleeding tendency or receiving thrombolytic or anticoagulant therapy, prophylactic use of low-dose aspirin or low molecular weight heparin; 10. Clinically obvious bleeding symptoms or obvious bleeding tendency within 3 months before inclusion, such as daily hemoptysis of 2.5ml or more, gastrointestinal bleeding, esophageal varicose veins with bleeding risk, gastric hemorrhagic ulcer or vasculitis; 11. Known hereditary or acquired bleeding and thrombosis (e.g. haemophiliacs, thrombocytopenia, thrombocytopenia, etc.); 12. Urine routine showed urinary protein >=++ and 24-hour urinary protein content > 1.0g; 13. Patient had an active infection, unexplained fever (>=38.5°C), or baseline white blood cell count > 15x10^9 / L within three days prior to administration; Patients with congenital or acquired immunodeficiency (e.g., those infected with HIV); 14. Bone metastases of > 4% of bone marrow area treated with palliative radiotherapy within 4 weeks before study participation; 15. The patient had previously received other anti-PD-1 antibody therapies or other immunotherapies targeting PD-1 / PD-L1, or had previously received Apatinib therapy; 16. Live vaccines were administered less than four weeks before the start of the study or possibly during the study period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy evaluation criteria for solid tumors -- RECIST 1.1;Progression free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival; | — |
Countries
China
Contacts
Public ContactPiao Longzhen
Affiliated Hospital of Yanbian University
Outcome results
None listed