Primary liver cancer
Conditions
Interventions
Experimental group:HAIC combined with camrelizumab and lenvatinib
Sponsors
Longyan Second Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-80 years, no gender limit; 2. Patients with primary hepatocellular carcinoma who are strictly in accordance with the clinical diagnostic criteria of the Guidelines for the Diagnosis and Treatment of Primary Liver Cancer (2019 edition) or diagnosed by histopathology or cytology, and have at least one measurable lesion (According to the mRECIST 1.1 standard, the long diameter of the measurable lesion on spiral CT scan is >= 10mm or the short diameter of the malignant lymph node is >= 15mm. See Annex 4 for mRECIST version 1.1); 3. Patients with unresectable primary hepatocellular carcinoma who have not received systemic therapy before; 4. CNLC stage is IIa-IIIb; 5. Child-Pugh grading of liver function is grade A or grade B (5-7 points); 6. ECOG PS score 0-1 points; 7. Expected survival period >= 12 weeks; 8. If the patient suffers from active hepatitis B virus (HBV) infection: if HBV-DNA 2000, antiviral treatment should be given for one week before starting treatment; 9. The main organs function normally and meet the following criteria: (1) The blood routine examination standards must meet: (no blood transfusion within 14 days) hemoglobin (HB) >= 100g/L, white blood cell count (WBC) >= 3x10^9/L, absolute neutrophil count (ANC) >= 1.5 x10^9/L, platelet (PLT)>=80x10^9/L; (2) Biochemical tests should meet the following criteria: bilirubin (BIL) <1.5 times the upper limit of normal (ULN), alanine aminotransferase (ALT) and aspartate aminotransferase AST <5ULN, serum creatinine (Cr) <=1.5ULN; 10. Women of childbearing age must have a negative pregnancy test (serum) or urine HCG test within 7 days before enrollment, and are willing to use appropriate methods of contraception during the trial and 8 weeks after the last administration of the trial drug; for males, surgical sterilization, or consent to use an appropriate method of contraception during the trial and 8 weeks after the last dose of the trial drug; 11. The patients voluntarily joined the study, had good compliance, and cooperated with the follow-up.
Exclusion criteria
Exclusion criteria: 1. During pregnancy or breastfeeding; 2. Patients with autoimmune diseases, organ/hematopoietic stem cell transplantation or other malignant tumors (except for cured skin basal cell carcinoma and cervical carcinoma in situ); 3. Patients with disturbance of consciousness or unable to cooperate with treatment, and patients with mental illness; 4. Patients who have participated in other clinical trials in the past three months; 5. Previously received local therapy (such as surgical resection, radiation therapy, interventional therapy, etc.), targeted therapy or other PD-1/PD-L1 inhibitor therapy; 6. Use immunosuppressive or systemic hormone therapy within 14 days before enrollment to achieve the purpose of immunosuppression (dose>10mg/day prednisone or other equivalent hormones); 7. Bleeding from esophageal (stomach fundus) varices within 1 month before treatment; 8. Uncorrectable coagulation dysfunction and severe blood abnormalities, severe bleeding tendency, and severe coagulation dysfunction that cannot withstand surgery (anticoagulation therapy and/or anticoagulant drugs should be discontinued for more than 1 week before radiotherapy); 9. Intractable massive ascites, cachexia; 10. Active infection, especially inflammation of the biliary system; 11. Those who are allergic to targeted drugs, any component of PD-1 monoclonal antibody or other experimental drugs of the same type in the past; 12. Those with high blood pressure that cannot be reduced to the normal range after antihypertensive drug treatment (systolic blood pressure>140 mmHg, diastolic blood pressure>90 mmHg); 13. Previous severe cardiovascular diseases, including but not limited to the following diseases: myocardial ischemia or myocardial infarction above grade II, and poorly controlled arrhythmias (including QTc interval >=450 ms for men and >=470 ms for women); according to the NYHA standard, the patients with grade III-IV cardiac insufficiency, or the left ventricular ejection fraction (LVEF) 1.0g); 15. Inability to swallow tablets, malabsorption syndrome or any condition that affects gastrointestinal absorption; 16. According to the judgment of the investigator, patients with other concomitant diseases that seriously endanger the patient's safety or affect the patient's completion of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Conversion rate;Safety; | — |
Secondary
| Measure | Time frame |
|---|---|
| Radical (R0) resection rate after conversion therapy;Pathological complete response rate (pCR);Major pathological response rate (MPR);Objective response rate;Disease control rate (DCR);Progression-free survival (PFS);Relapse-free survival time (RFS);Overall survival (OS); | — |
Countries
China
Contacts
Public ContactJian Yizeng
Longyan Second Hospital
Outcome results
None listed