liver cancer
Conditions
Interventions
Experimental group:Hepatic arterial infusion chemotherapy (FOLFOX) combined with camrelizumab and apatinib
Sponsors
The First Hospital of China Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-80 years (counting from the date of signing the informed consent form); 2. Patients with histopathologically confirmed primary hepatocellular carcinoma who have not previously received immunocheckpoint inhibitor therapy, molecular targeted therapy or TACE therapy have progressed; 3. Imaging showed the presence of main portal vein cancer thrombus (Cheng Grade III); 4. Child-Pugh rating is A grade or good B grade (=3 months; 7. At least one measurable lesion according to RECIST 1.1 and mRECIST criteria; 8. Asymptomatic BMS or BMS have been controlled; 9. Routine laboratory tests (blood routine, liver and kidney function, coagulation function, etc.) showed no significant abnormalities: (1) The standard of blood routine examination shall meet (no blood transfusion or blood products within 14 days) : ANC>=1.5x10^9/L; PLT>=50x10^9/L; (2) Biochemical examination should meet the following criteria: TBIL 45ml/min (Cockcroft-Gault formula); 10. Patients with potential fertility need to use a medically approved contraceptive (such as an intrauterine device, contraceptive or condom) during the study treatment period and for one month after the study treatment period ends; Serum or urine HCG tests must be negative within 72 hours prior to study enrollment and must be non-lactating; 11. The patients voluntarily participated in the study and signed the informed consent, with good compliance and follow-up.
Exclusion criteria
Exclusion criteria: 1. Fibrolamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, cholangiocarcinoma and other components previously confirmed by histology/cytology; 2. Have a history of hepatic encephalopathy or liver transplantation; 3. Allergic history to the test drug: carrilizumab, carrilizumab any component; 4. There are complications requiring treatment, such as ascites, pleural effusion and pericardial effusion with clinical symptoms, that is, therapeutic puncture or drainage is required, or active bleeding exists in the unresected tumor; 5. History of interstitial lung disease (except radiation pneumonia without hormone therapy) and non-infectious pneumonia; 6. Have an active, known, or suspected autoimmune disease (including, but not limited to, uveitis, enteritis, hepatitis, pituitaritis, nephritis, vasculitis, hyperthyroidism, hypothyroidism, and asthma requiring bronchodilator treatment), hypothyroidism requiring hormone replacement therapy, and skin conditions requiring no systemic treatment (such as vitiligo, psoriasis, or alopecia) may be enrolled; 7. Subjects who were taking immunosuppressant, systemic, or absorbable topical hormone therapy for immunosuppressive purposes (dose > 10mg/ day prednisone or other therapeutic hormone) and continued to use within 2 weeks prior to enrollment; 8. Severe infections (CTCAE > Grade 2), such as severe pneumonia, bacteremia, and infection complications requiring hospitalization, occurred 4 weeks prior to the first use of the study drug; Baseline chest imaging indicated active pulmonary inflammation, signs and symptoms of infection within 2 weeks prior to initial use of the study drug, or the need for oral and intravenous antibiotic treatment, except for the use of prophylactic antibiotics; 9. The subjects had acute cardiovascular and cerebrovascular diseases such as acute cerebral infarction and acute coronary syndrome within 1 month, and their cardiovascular clinical symptoms or diseases were not well controlled; 10. Poorly controlled heart disease, such as: (1) New York Heart Association (NYHA) Grade 2 + heart failure; (2) LVEF (left ventricular ejection fraction) was less than 50% by color Doppler ultrasonography; (3) Unstable angina; (4) Myocardial infarction occurred within 1 year; (5) Supraventricular or ventricular arrhythmias that have clinical significance and require treatment or intervention; 11. Subjects with a definite tendency to gastrointestinal bleeding, including the following conditions: locally active ulcer lesions and fecal occult blood {(++) not included in the group}; Subjects with history of black stool and hematemesis within 2 months; According to ERCP/CT/DSA, it has a high risk of esophageal and gastric varices rupture and bleeding; 12. Have hypertension that is not well controlled by antihypertensive medications (systolic blood pressure >=140 mmHg or diastolic blood pressure >=90 mmHg); 13. Known history of human immunodeficiency virus (HIV) infection (i.e. HIV 1/2 antibody positive), known active syphilis; 14. Tuberculosis that is active or currently requiring medical intervention, including but not limited to tuberculosis; 15. Long-term unhealed wounds or fractures, major surgical procedures or severe traumatic injuries, fractures or ulcers within 4 weeks; 16. Active hepatitis B or C (hepatitis B HBV-DNA>=2000IU/ml; Hepatitis C: HCV antibody and HCV-DNA positive, need antiviral therapy); 17. Receiving a potent CYP3A4 inhibitor within 7
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate of intrahepatic lesions;Objective response rate;Duration of remission;Overall survival;Safety;Quality of life score; | — |
Countries
China
Contacts
Public ContactShao Haibo
Outcome results
None listed