Hepatocellular Carcinoma
Conditions
Interventions
Treatment Group:RALOX-HAIC combined with carrilizumab and Apatinib mesylate
Sponsors
Drum Tower Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Join the group voluntarily and sign a written informed consent; 2.(2) Age 18 ~ 80 years old (including 80 years old), male and female; 3.(3) Patients with locally advanced hepatocellular carcinoma that is clinically diagnosed or histologically/cytologically confirmed as unresectable according to the Guidelines for the Diagnosis and Treatment of Primary Liver Cancer (2024 Edition); 4.(4) did not receive systematic anti-tumor therapy. 5.(5) Combined with portal vein cancer thrombus (Vp type: Vp3, Vp4;Or Cheng type: Type II or III) of CNLC Stage IIIa or BCLC Stage C hepatocellular carcinoma. 6.(6) there is at least one evaluable lesion (RECIST1.1 criteria); 7.(7) Expected survival time >= 3 months; 8.(8) The physical status (PS) score of ECOG was 0 ~ 1; 9.(9)Child-Pugh grade A; 10.(10) Major organ function is normal, that is, meet the following criteria: routine blood test: hemoglobin >= 90g/L, neutrophil >= 1.5×109/L, platelet count >= 75×109/L;Biochemical test: albumin >= 28g/L, total bilirubin <= 3× upper limit of normal value (ULN), aspartate aminotransferase (AST), alanine aminotransferase (ALT) <= 5×ULN, alkaline phosphatase (ALP) <= 5×ULN, creatinine <= 1.5×ULN, coagulation function:International Standardized ratio (INR) or prothrombin time (PT) <= 1.5×ULN, activated partial thromboplastin time (APTT) <= 1.5×ULN; 11.(11) Have a record of hepatitis virological status, confirmed by serological testing for hepatitis B virus (HBV) and hepatitis C virus (HCV).Patients with active HBV received anti-HBV therapy for at least 14 days prior to initiation of carrellizumab and apatinib mesylate and were willing to continue anti-HBV therapy over the course of the study. 12.(12) Women of reproductive age should have a negative serum or urine pregnancy test within 14 days prior to inclusion in the study, must be non-lactating women, and patients should consent to the use of contraceptives during medication and for 60 days after the end of medication;The definition of "fertile woman" and contraceptive guidelines are in Appendix 5; 13.(13) The subjects had good compliance and cooperated with follow-up.
Exclusion criteria
Exclusion criteria: 1. There are other primary malignant tumors; 2.(2) Evidence of extrahepatic metastases confirmed by CT and/or MRI scans of the chest, abdomen and pelvis; 3.(3) There is clinically significant ascites; 4.(4) Have a history of hepatic encephalopathy; 5.(5) A history of idiopathic pulmonary fibrosis, institutional pneumonia (such as bronchiolitis obliterans), drug-induced pneumonia, or idiopathic pneumonia, or evidence of active pneumonia on chest CT scan at screening. (6) Severe infection within 4 weeks, including but not limited to hospitalization due to infection complications, bacteremia, or severe pneumonia; 6.(7) A history of hypertensive crisis or hypertension, major cardiovascular disease (such as New York Heart Society Class II or worse heart disease, myocardial infarction, or cerebrovascular accident), unstable arrhythmia, or unstable angina in the 3 months prior to initiation of study treatment. Inadequate control of arterial hypertension (defined as systolic blood pressure (BP) >= 150mmHg and/or diastolic blood pressure >100mmHg) (based on the average of >= 3 BP readings obtained from >= 2 measurements) - allows the above parameters to be achieved through the use of antihypertensive therapy. (9) Have had serious vascular disease within six months (e.g. aortic aneurysm requiring surgical repair or recent history of peripheral autoimmune disease or immune deficiency),Including, but not limited to, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antilecipid antibody syndrome, Wegener granulomatosis, Sjogren's syndrome, Guillain-Barre syndrome, or arterial thrombosis in multiple sclerosis); 7.(10) Contraindicated use of the investigational drug, any other disease, metabolic dysfunction, physical examination findings or clinical laboratory findings that may affect the interpretation of the results or may place the patient at a high risk of treatment complications; 8.(11) systemic immunosuppressive drugs (including but not limited to glucocorticoids, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor-a [TNF-a] preparations) within 2 weeks, or systemic immunosuppressive drugs are expected to be required during the study treatment; 9.(12) Evidence of bleeding tendency or severe clotting disorder; 10.(13) Patients who are preparing for or have previously received an organ or allogeneic bone marrow transplant; 11.(14) Use of strong CYP3A4/CYP2C19 inducers including rifampicin (and its analogues) and hypericum perforatum or strong CYP3A4/CYP2C19 inhibitors within 14 days prior to initiation of study therapy;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR;Surgical conversion rate;Radical resection rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| pRFS;pCR, MPR;DOR;DCR;EORTCQLQ-C30;OS;PFS;Single cell sequencing results and potential target analysis of puncture samples;Tumor marker alteration;ORR rate of portal vein tumor thrombus;PFS of portal vein tumor thrombus;Surgical complications;Adverse events and their classification; | — |
Countries
China
Contacts
Public ContactXinhua Zhu
Drum Tower Hospital
Outcome results
None listed