hepatocellular carcinoma
Conditions
Interventions
Group 1:Hepatic arterial infusion of FOLFOX regimen and adebrelimab combine with intravenous injection of bevacizumab
Group 2:Hepatic arterial infusion of FOLFOX regimen combine with intravenous injection of adebrelimab and bevacizumab
Sponsors
Sun Yat-sen University Cancer Center
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Voluntarily participate in this study and sign an informed consent form; 2. Age >= 18 (calculated from the day of signing informed consent); 3. Clinical or pathological diagnosed Hepatocellular carcinoma; 4. BCLC stage C, accompanied by vascular/biliary invasion or distant metastasis (except for patients with Vp 4 tumor thrombus); 5. Haven't received systemic treatment since diagnosis; for patients who have undergone local treatment for HCC (including but not limited to surgery, ablation, radiotherapy, TACE, etc.) and have progressed or with residual lesions, the time between local treatment and enrollment should not be less than one month; 6. ECOG PS score 0-1 points; Child Pugh score A or B 7; 7. No history of autoimmune diseases; 8. Expected lifespan = 3 months; 9. At least have one measurable lesion (according to RECIST v1.1 requirements, the measurable lesion has a spiral CT scan length of = 10 mm or an enlarged lymph node with short diameter of = 15 mm; lesions that have received local treatment in the past can be used as target lesions after clear progression according to RECIST v1.1 criteria); 10. Adequate blood, liver, and kidney function, laboratory tests conducted within one week prior to enrollment meet the following criteria: Neutrophils = 1.5 × 10 ^ 9/L; Platelets = 75 × 10 ^ 9/L; Hemoglobin = 90g/L; Serum ALT and AST = 5 times the upper limit of normal (ULN); Serum creatinine = 1.5 × ULN; International normalized ratio INR<2.3, or prothrombin time = ULN+6 seconds; Albumin = 30g/L; Total bilirubin = 3 × ULN. 11. Women of childbearing age should have a negative serum or urine pregnancy test within 7 days before enrollment in the study, and must be non-lactating patients, and agree to use contraceptive measures during the study period and within 6 months after the end of the study; Men should agree to use contraceptive measures during the study period and within 6 months after the end of the study period.
Exclusion criteria
Exclusion criteria: 1. Patients who are severely allergic to iodine contrast agents and could not finish HAIC treatment; 2. Use immunosuppressants or systemic hormone therapy within the first month of randomization; 3. With active infections that cannot be effectively controlled; 4. Severe gastric fundus esophageal varices; Untreated or incompletely treated gastroesophageal varices (with bleeding or high risk of bleeding); 5. Brain metastases or bone metastases accompanied requiring emergency intervention by surgery or radiation therapy; 6. Pregnant or suspected pregnant, or breastfeeding; 7. Currently using or recently using (within 10 days before the start of study treatment) aspirin (>325mg/day (maximum antiplatelet dose) or treatment with dipyridamole, ticlopidine, clopidogrel, and cilostazol; 8. Thrombotic or embolic event has occurred within the 6 months prior to the start of treatment, such as a cerebrovascular accident (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), pulmonary embolism, etc; 9. Patients with congenital or acquired immune dysfunction; 10. Accompanied by a history of other malignant tumors; 11. Any of the following conditions occurred in the 12 months prior to the start of the study: myocardial infarction, severe/unstable angina, congestive heart failure; 12. Patients with renal insufficiency who require dialysis; 13. History of organ transplantation; 14. Patients with other serious acute or chronic physiological or mental illnesses or abnormal laboratory tests may increase the research risk or interfere with the interpretation of results, making them unsuitable for enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall response rate by RECIST v1.1; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival;Progression Free Survival;Overall Response Rate by mRECIST;Disease Control Rate by mRECIST;Duration of Response by mRECIST ; | — |
Countries
China
Contacts
Public ContactWeijun Fan
Sun Yat-sen University Cancer Center
Outcome results
None listed